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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Differential Rate Kinetic Method, Cpk Or Isoenzymes
510(k) Number K872029
Device Name UNI-FAST CREATINE KINASE TEST (CK)
Applicant
Sclavo, Inc.
5 Mansard Ct.
Wayne,  NJ  07470
Applicant Contact KING, PH.D.
Correspondent
Sclavo, Inc.
5 Mansard Ct.
Wayne,  NJ  07470
Correspondent Contact KING, PH.D.
Regulation Number862.1215
Classification Product Code
JHS  
Date Received05/26/1987
Decision Date 06/17/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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