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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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