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510(k) K981218

CREATINE KINASE (CK) by Abbott Laboratories — Product Code CGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1998
Date Received
April 3, 1998
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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