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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Estradiol
510(k) Number K970643
Device Name VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)
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 Number862.1260
Classification Product Code
CHP  
Subsequent Product Code
JIS  
Date Received02/20/1997
Decision Date 03/18/1997
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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