Cleared Traditional

SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5

K992801 · Sigma Diagnostics, Inc. · Chemistry
Sep 1999
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K992801 is an FDA 510(k) clearance for the SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5, a Nadh Oxidation/nad Reduction, Ast/sgot (Class II — Special Controls, product code CIT), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on September 28, 1999, 40 days after receiving the submission on August 19, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K992801 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 1999
Decision Date September 28, 1999
Days to Decision 40 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CIT — Nadh Oxidation/nad Reduction, Ast/sgot
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1100

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