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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoassay Method, Troponin Subunit
510(k) Number K012820
Device Name AIA-PACK CTNI 2ND-GEN ASSAY
Applicant
Tosoh Medics, Inc.
347 Oyster Point Blvd.,
Suite 201
South San Francisco,  CA  94080
Applicant Contact LOIS NAKAYAMA
Correspondent
Tosoh Medics, Inc.
347 Oyster Point Blvd.,
Suite 201
South San Francisco,  CA  94080
Correspondent Contact LOIS NAKAYAMA
Regulation Number862.1215
Classification Product Code
MMI  
Subsequent Product Code
JIT  
Date Received08/23/2001
Decision Date 12/14/2001
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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