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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 K984359
Device Name AIA-PACK TROPONIN I ASSAY
Applicant
Tosoh Medics, Inc.
347 Oyster Pt. Blvd.,
Suite 201
South San Francisco,  CA  94080
Applicant Contact LORI ROBINSON
Correspondent
Tosoh Medics, Inc.
347 Oyster Pt. Blvd.,
Suite 201
South San Francisco,  CA  94080
Correspondent Contact LORI ROBINSON
Regulation Number862.1215
Classification Product Code
MMI  
Date Received12/07/1998
Decision Date 12/23/1998
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
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