Cleared Traditional

CREATINE KINASE (COLORIMETRIC METHOD)

K880178 · Tech-Co, Inc. · Chemistry
Feb 1988
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K880178 is an FDA 510(k) clearance for the CREATINE KINASE (COLORIMETRIC METHOD), a Colorimetric Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHY), submitted by Tech-Co, Inc. (Oak Park, US). The FDA issued a Cleared decision on February 18, 1988, 34 days after receiving the submission on January 15, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K880178 FDA.gov
FDA Decision Cleared SESE
Date Received January 15, 1988
Decision Date February 18, 1988
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JHY — Colorimetric Method, Cpk Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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