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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K973030
Device Name VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300)
Applicant
Johnson & Johnson Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester,  NY  14650
Applicant Contact ANN M QUINN
Correspondent
Johnson & Johnson Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester,  NY  14650
Correspondent Contact ANN M QUINN
Regulation Number862.1660
Classification Product Code
JJY  
Subsequent Product Codes
JHX   JIX  
Date Received08/14/1997
Decision Date 09/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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