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510(k) K972155

CREATINE KINASE (CK) by Stanbio Laboratory — Product Code CGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1997
Date Received
June 5, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

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  • K032482 — STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM (October 24, 2003)
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