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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Luteinizing Hormone
510(k) Number K964982
Device Name VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)
Applicant
Johnson & Johnson Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester,  NY  14650 -0882
Applicant Contact ANN M QUINN
Correspondent
Johnson & Johnson Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester,  NY  14650 -0882
Correspondent Contact ANN M QUINN
Regulation Number862.1485
Classification Product Code
CEP  
Date Received12/12/1996
Decision Date 02/20/1997
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
Recalls CDRH Recalls
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