Cleared Traditional

PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT

K912231 · Intl. Immunoassay Laboratories, Inc. · Chemistry
Jul 1991
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K912231 is an FDA 510(k) clearance for the PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT, a U.v. Method, Cpk Isoenzymes (Class II — Special Controls, product code JHW), submitted by Intl. Immunoassay Laboratories, Inc. (Santa Clara, US). The FDA issued a Cleared decision on July 8, 1991, 49 days after receiving the submission on May 20, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K912231 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 1991
Decision Date July 08, 1991
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JHW — U.v. Method, Cpk Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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