CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT— 510(k) K810853

Name: FDA 510(k) clearance K810853
Creator: U.S. Food and Drug Administration
Published: 1981-05-29

Substantially Equivalent

The Upjohn Co.

FDA 510(k) clearance K810853 for CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT, Substantially Equivalent on 1981-05-29. Applicant: The Upjohn Co.. Device class: 2.

Clearance details

Applicant: The Upjohn Co.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1981-03-30
Decision date: 1981-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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