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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Myoglobin, Antigen, Antiserum, Control
510(k) Number K981012
Device Name AIA-PACK MYOGLOBIN 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 Number866.5680
Classification Product Code
DDR  
Date Received03/18/1998
Decision Date 05/28/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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