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.
| AMDL, Inc. | ||||
| July 7, 2008 | By: |
Gary L. Dreher
|
||
| Name: Gary L. Dreher | ||||
| Title: Chief Executive Officer | ||||
Exhibit Index
| Exhibit No. | Description | |
|
99.1
|
Press Release Re FDA Determination Letter on DR-70 dated July 7, 2008 |