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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
Recalls CDRH Recalls
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