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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nad reduction/nadh oxidation, cpk or isoenzymes
510(k) Number K972155
Device Name CREATINE KINASE (CK)
Applicant
STANBIO LABORATORY
2930 EAST HOUSTON ST.
SAN ANTONIO,  TX  78202
Applicant Contact KIRK JOHNSON
Correspondent
STANBIO LABORATORY
2930 EAST HOUSTON ST.
SAN ANTONIO,  TX  78202
Correspondent Contact KIRK JOHNSON
Regulation Number862.1215
Classification Product Code
CGS  
Date Received06/05/1997
Decision Date 07/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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