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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Vitamin D
510(k) Number K123131
Device Name ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AI
Applicant
Tosoh Bioscience, Inc.
6000 Shoreline Court, Suite 101
South San Franciso,  CA  94080
Applicant Contact ROBERT L WICK
Correspondent
Tosoh Bioscience, Inc.
6000 Shoreline Court, Suite 101
South San Franciso,  CA  94080
Correspondent Contact ROBERT L WICK
Regulation Number862.1825
Classification Product Code
MRG  
Subsequent Product Codes
JIT   JJX  
Date Received10/04/2012
Decision Date 02/08/2013
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
Predetermined Change
Control Plan Authorized		 No
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