Cleared Traditional

ACETAMINOPHEN SERUM TOX EIA ASSAY

K961373 · Diagnostic Reagents, Inc. · Toxicology
Jul 1996
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K961373 is an FDA 510(k) clearance for the ACETAMINOPHEN SERUM TOX EIA ASSAY, a Colorimetry, Acetaminophen (Class II — Special Controls, product code LDP), submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on July 8, 1996, 90 days after receiving the submission on April 9, 1996. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3030.

Submission Details

510(k) Number K961373 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 1996
Decision Date July 08, 1996
Days to Decision 90 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LDP — Colorimetry, Acetaminophen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3030

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