CREATINE KINASE (COLORIMETRIC METHOD)— 510(k) K880178

Name: FDA 510(k) clearance K880178
Creator: U.S. Food and Drug Administration
Published: 1988-02-18

Substantially Equivalent

Tech-Co, Inc.

FDA 510(k) clearance K880178 for CREATINE KINASE (COLORIMETRIC METHOD), Substantially Equivalent on 1988-02-18. Applicant: Tech-Co, Inc.. Device class: 2.

Clearance details

Applicant: Tech-Co, Inc.
Product code: Code JHY
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1988-01-15
Decision date: 1988-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oak Park, MI, US

Download summary PDF View on FDA.gov ↗

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