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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name radioimmunoassay, testosterones and dihydrotestosterone
510(k) Number K143075
Device Name ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set
Applicant
TOSOH BIOSCIENCE, INC.
6000 SHORELINE COURT
SUITE 101
south san francisco,  CA  94080
Applicant Contact robert l wick
Correspondent
TOSOH BIOSCIENCE, INC.
6000 SHORELINE COURT
SUITE 101
south san francisco,  CA  94080
Correspondent Contact robert l wick
Regulation Number862.1680
Classification Product Code
CDZ  
Subsequent Product Code
JIT  
Date Received10/27/2014
Decision Date 07/02/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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