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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 K904814
Device Name GLYC-AFFIN GP
Applicant
ISOLAB, INC.
drawer 4350
akron,  OH  44321
Applicant Contact loren f hazelwood
Correspondent
ISOLAB, INC.
drawer 4350
akron,  OH  44321
Correspodent Contact loren f hazelwood
Regulation Number864.7470
Classification Product Code
LCP  
Date Received10/24/1990
Decision Date 12/26/1990
Decision substantially equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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