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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 K023091
Device Name ST AIA-PACK TESTOSTERONE ASSAY
Applicant
TOSOH MEDICS, INC.
347 OYSTER POINT BLVD.,
SUITE 201
san francisco,  CA  94080
Applicant Contact lois nakayama
Correspondent
TOSOH MEDICS, INC.
347 OYSTER POINT BLVD.,
SUITE 201
san francisco,  CA  94080
Correspondent Contact lois nakayama
Regulation Number862.1680
Classification Product Code
CDZ  
Date Received09/17/2002
Decision Date 12/17/2002
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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