Cleared Traditional

FIRST SIGN DRUG OF ABUSE SCREENING TEST

K032575 · W.H.P.M., Inc. · Chemistry
May 2004
Decision
273d
Days
Class 2
Risk

About This 510(k) Submission

K032575 is an FDA 510(k) clearance for the FIRST SIGN DRUG OF ABUSE SCREENING TEST, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by W.H.P.M., Inc. (Beverly, US). The FDA issued a Cleared decision on May 19, 2004, 273 days after receiving the submission on August 20, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K032575 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 2003
Decision Date May 19, 2004
Days to Decision 273 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DKZ — Enzyme Immunoassay, Amphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

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