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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 K862371
Device Name HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C)
Applicant
Bio-Rad
2400 Wright Ave.
Richmond,  CA  94804
Applicant Contact FRANK MATARRESE
Correspondent
Bio-Rad
2400 Wright Ave.
Richmond,  CA  94804
Correspondent Contact FRANK MATARRESE
Regulation Number864.7470
Classification Product Code
LCP  
Date Received06/24/1986
Decision Date 09/16/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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