Cleared Special

EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229

K012257 · Syva Co. · Chemistry
Aug 2001
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K012257 is an FDA 510(k) clearance for the EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Syva Co. (Cupertino, US). The FDA issued a Cleared decision on August 3, 2001, 16 days after receiving the submission on July 18, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K012257 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2001
Decision Date August 03, 2001
Days to Decision 16 days
Submission Type Special
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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