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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Folic, Radioimmunoassay
510(k) Number K091332
Device Name AIA-PACK RBC FOLATE
Applicant
Tosoh Bioscience, Inc.
3600 Gantz Rd.
Grove City,  OH  43123
Applicant Contact CHARLES P GILL
Correspondent
Tosoh Bioscience, Inc.
3600 Gantz Rd.
Grove City,  OH  43123
Correspondent Contact CHARLES P GILL
Regulation Number862.1295
Classification Product Code
CGN  
Date Received05/06/2009
Decision Date 10/02/2009
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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