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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 K810714
Device Name LANCER GLYCOSYLATED HEMOGLOBIN ASSAY
Applicant
SHERWOOD MEDICAL CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SHERWOOD MEDICAL CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number864.7470
Classification Product Code
LCP  
Date Received03/17/1981
Decision Date 05/08/1981
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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