Cleared Traditional

BENZODIAZEPINE SERUM TOX EIA TEST

K960708 · Diagnostic Reagents, Inc. · Toxicology
May 1996
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K960708 is an FDA 510(k) clearance for the BENZODIAZEPINE SERUM TOX EIA TEST, a Enzyme Immunoassay, Benzodiazepine (Class II — Special Controls, product code JXM), submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on May 20, 1996, 89 days after receiving the submission on February 21, 1996. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3170.

Submission Details

510(k) Number K960708 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 1996
Decision Date May 20, 1996
Days to Decision 89 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

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

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