Cleared Special

EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229

K011306 · Syva Co., Dade Behring, Inc. · Toxicology
May 2001
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K011306 is an FDA 510(k) clearance for the EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229, a Enzyme Immunoassay, Benzodiazepine (Class II — Special Controls, product code JXM), submitted by Syva Co., Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on May 16, 2001, 16 days after receiving the submission on April 30, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3170.

Submission Details

510(k) Number K011306 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 2001
Decision Date May 16, 2001
Days to Decision 16 days
Submission Type Special
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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