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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
Recalls CDRH Recalls
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