Cleared Traditional

CARESIDE AST

K990009 · Careside, Inc. · Chemistry
Mar 1999
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K990009 is an FDA 510(k) clearance for the CARESIDE AST, a Nadh Oxidation/nad Reduction, Ast/sgot (Class II — Special Controls, product code CIT), submitted by Careside, Inc. (Culver City, US). The FDA issued a Cleared decision on March 16, 1999, 71 days after receiving the submission on January 4, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K990009 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 1999
Decision Date March 16, 1999
Days to Decision 71 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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