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510(k) K880178

CREATINE KINASE (COLORIMETRIC METHOD) by Tech-Co, Inc. — Product Code JHY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1988
Date Received
January 15, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetric Method, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

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