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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 K803186
Device Name NORMAL AND ELEVATED CONTROL FOR GLYCO.
Applicant
APPLIED CLINICAL RESEARCH LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
APPLIED CLINICAL RESEARCH LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number864.7470
Classification Product Code
LCP  
Date Received12/16/1980
Decision Date 01/21/1981
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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