Cleared Traditional

BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST

K002342 · Branan Medical Corporation · Toxicology
Nov 2000
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K002342 is an FDA 510(k) clearance for the BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST, a Enzyme Immunoassay, Benzodiazepine (Class II — Special Controls, product code JXM), submitted by Branan Medical Corporation (Irvine, US). The FDA issued a Cleared decision on November 27, 2000, 118 days after receiving the submission on August 1, 2000. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3170.

Submission Details

510(k) Number K002342 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2000
Decision Date November 27, 2000
Days to Decision 118 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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