Amdl Inc - Current report filing (8-K)
July 07 2008 - 11:55AM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Date of Report (Date of Earliest Event Reported):
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July 3, 2008
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AMDL, Inc.
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(Exact name of registrant as specified in its charter)
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Delaware
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0-27689
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33-0413161
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(State or other jurisdiction
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(Commission
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(I.R.S. Employer
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of incorporation)
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File Number)
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Identification No.)
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2492 Walnut Avenue, Suite 100, Tustin, California
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92780
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(Address of principal executive offices)
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(Zip Code)
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Registrants telephone number, including area code:
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714-505-4461
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Not Applicable
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Former name or former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any
of the following provisions:
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 7.01 Regulation FD Disclosure.
On July 7, 2008, we issued a press release announcing the receipt of a letter of determintion from the United States Food and Drug Administration ("FDA")with regard to DR-70. A copy of the press release is furnished herewith as Exhibit 99.1 and incorporated by this reference
Item 8.01 Other Events.
On July 3, 2008, we received a letter of determination from the FDA that the Registrant's DR-70 ELISA tumor-associated antigen immunoligical test system was "substantially equivalent" to the existing predicate device being marketed. The letter grants Registrant the right to market the DR-70 test as a device to monitor patients who have been previously diagnosed with colorectal cancer.
Item 9.01 Financial Statements and Exhibits.
(c) Exhibits.
99.1 Press release, dated July 7, 2008 announcing the FDA's determination.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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AMDL, Inc.
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July 7, 2008
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By:
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Gary L. Dreher
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Name: Gary L. Dreher
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Title: Chief Executive Officer
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Exhibit Index
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Exhibit No.
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Description
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99.1
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Press Release Re FDA Determination Letter on DR-70 dated July 7, 2008
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