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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 K992365
Device Name AIA-PACK FOLATE ASSAY
Applicant
Tosoh Medics, Inc.
347 Oyster Pt. Blvd.,
Suite 201
South San Francisco,  CA  94080
Applicant Contact JUDITH E LOEBEL
Correspondent
Tosoh Medics, Inc.
347 Oyster Pt. Blvd.,
Suite 201
South San Francisco,  CA  94080
Correspondent Contact JUDITH E LOEBEL
Regulation Number862.1295
Classification Product Code
CGN  
Date Received07/15/1999
Decision Date 08/10/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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