Cleared Traditional

EMIT II OPIATES 300/2000 ASSAY

K971596 · Behring Diagnostics, Inc. · Toxicology
Jun 1997
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K971596 is an FDA 510(k) clearance for the EMIT II OPIATES 300/2000 ASSAY, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Behring Diagnostics, Inc. (San Jose, US). The FDA issued a Cleared decision on June 25, 1997, 55 days after receiving the submission on May 1, 1997. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K971596 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 1997
Decision Date June 25, 1997
Days to Decision 55 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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