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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name assay, glycosylated hemoglobin
510(k) Number K871388
Device Name MICROMAT MODEL 415 - BICHROMATIC FILTER PHOTOMETER
Applicant
BIO-RAD
4000 alfred nobel dr.
hercules,  CA  94547 -1803
Applicant Contact frank matarrese
Correspondent
BIO-RAD
4000 alfred nobel dr.
hercules,  CA  94547 -1803
Correspondent Contact frank matarrese
Regulation Number864.7470
Classification Product Code
LCP  
Date Received04/07/1987
Decision Date 07/06/1987
Decision substantially equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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