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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 K964349
Device Name AIA-PACK FOLATE ASSAY
Applicant
TOSOH MEDICS, INC.
373 VINTAGE PARK DR.
SUITE D
FOSTER CITY,  CA  94404
Applicant Contact LORI ROBINSON
Correspondent
TOSOH MEDICS, INC.
373 VINTAGE PARK DR.
SUITE D
FOSTER CITY,  CA  94404
Correspondent Contact LORI ROBINSON
Regulation Number862.1295
Classification Product Code
CGN  
Date Received10/31/1996
Decision Date 11/27/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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