Cleared Traditional

SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL

K993985 · Syva Co. · Toxicology
Jan 2000
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K993985 is an FDA 510(k) clearance for the SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL, a Enzyme Immunoassay, Benzodiazepine (Class II — Special Controls, product code JXM), submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on January 27, 2000, 64 days after receiving the submission on November 24, 1999. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3170.

Submission Details

510(k) Number K993985 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 1999
Decision Date January 27, 2000
Days to Decision 64 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code JXM — Enzyme Immunoassay, Benzodiazepine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3170

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