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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Total Triiodothyronine
510(k) Number K964310
Device Name VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010)
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 Number862.1710
Classification Product Code
CDP  
Subsequent Product Code
JIS  
Date Received10/29/1996
Decision Date 11/27/1996
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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