UNI-FAST CREATINE KINASE TEST (CK)— 510(k) K872029

Name: FDA 510(k) clearance K872029
Creator: U.S. Food and Drug Administration
Published: 1987-06-17

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K872029 for UNI-FAST CREATINE KINASE TEST (CK), Substantially Equivalent on 1987-06-17. Applicant: Sclavo, Inc.. Device class: 2.

Clearance details

Applicant: Sclavo, Inc.
Product code: Code JHS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1987-05-26
Decision date: 1987-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayne, NJ, US

Download summary PDF View on FDA.gov ↗

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