CREATINE KINASE (CK-NAC)— 510(k) K013912

Substantially Equivalent

Jas Diagnostics, Inc.

FDA 510(k) clearance K013912 for CREATINE KINASE (CK-NAC), Substantially Equivalent on 2002-01-18. Applicant: Jas Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Jas Diagnostics, Inc.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 2001-11-27
Decision date: 2002-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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