Cleared Traditional

BARBITURATE SERUM TOX EIA ASSAY

K960664 · Diagnostic Reagents, Inc. · Toxicology
May 1996
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K960664 is an FDA 510(k) clearance for the BARBITURATE SERUM TOX EIA ASSAY, a Enzyme Immunoassay, Barbiturate (Class II — Special Controls, product code DIS), submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on May 6, 1996, 80 days after receiving the submission on February 16, 1996. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3150.

Submission Details

510(k) Number K960664 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 1996
Decision Date May 06, 1996
Days to Decision 80 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DIS — Enzyme Immunoassay, Barbiturate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3150

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