Cleared Traditional

CARESIDE CKMB

K990434 · Careside, Inc. · Chemistry
Apr 1999
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K990434 is an FDA 510(k) clearance for the CARESIDE CKMB, a Differential Rate Kinetic Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHS), submitted by Careside, Inc. (Culver City, US). The FDA issued a Cleared decision on April 19, 1999, 67 days after receiving the submission on February 11, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K990434 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 1999
Decision Date April 19, 1999
Days to Decision 67 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JHS — Differential Rate Kinetic Method, Cpk Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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