Cleared Traditional

SALICYLATE ASSAY

K961131 · Diagnostic Reagents, Inc. · Toxicology
Apr 1996
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K961131 is an FDA 510(k) clearance for the SALICYLATE ASSAY, a Colorimetry, Salicylate (Class II — Special Controls, product code DKJ), submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on April 29, 1996, 39 days after receiving the submission on March 21, 1996. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3830.

Submission Details

510(k) Number K961131 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 1996
Decision Date April 29, 1996
Days to Decision 39 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DKJ — Colorimetry, Salicylate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3830

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