Cleared Special

K010651 - AT HOME DRUG TEST, MODEL 9133 T
(FDA 510(k) Clearance)

K010651 · Phamatech · Toxicology device

Mar 2001

Decision

25d

Days

—

Risk

K010651 is an FDA 510(k) clearance for the AT HOME DRUG TEST, MODEL 9133 T. This device is classified as a Enzyme Immunoassay, Phencyclidine.

Submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on March 30, 2001, 25 days after receiving the submission on March 5, 2001.

This device falls under the Toxicology FDA review panel.

Submission Details

510(k) Number	K010651 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 05, 2001
Decision Date	March 30, 2001
Days to Decision	25 days
Submission Type	Special
Review Panel	Toxicology (TX)
Summary	Summary PDF