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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name urinary homocystine (nonquantitative) test system
510(K) Number K121533
Model 025226,025326, AND 025426
Device Name ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET
Applicant
TOSOH BIOSCIENCE, INC.
6000 shoreline court
suite 101
south san francisco,  CA  94080
Contact robert wick
Regulation Number862.1377
Classification Product Code
LPS  
Subsequent Product Codes
JIT   JJX  
Date Received05/25/2012
Decision Date 06/15/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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