Cleared Traditional

BARBITURATE EIA ESSAY (MODIFICATION)

K955928 · Diagnostic Reagents, Inc. · Toxicology
Mar 1996
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K955928 is an FDA 510(k) clearance for the BARBITURATE EIA ESSAY (MODIFICATION), 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 March 11, 1996, 84 days after receiving the submission on December 18, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3150.

Submission Details

510(k) Number K955928 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 1995
Decision Date March 11, 1996
Days to Decision 84 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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