Cleared Special

K001397 - QUICKSCREEN PRO DRUG CUP, MODEL 9195X
(FDA 510(k) Clearance)

K001397 · Phamatech · Toxicology

May 2000

Decision

23d

Days

Class 2

Risk

K001397 is an FDA 510(k) clearance for the QUICKSCREEN PRO DRUG CUP, MODEL 9195X, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on May 26, 2000, 23 days after receiving the submission on May 3, 2000. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number	K001397 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 03, 2000
Decision Date	May 26, 2000
Days to Decision	23 days
Submission Type	Special
Review Panel	Toxicology (TX)
Summary	Summary PDF