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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 K800857
Device Name HELENA GLYCOSYLATED HEMOGLOBIN QUIK METH
Applicant
HELENA LABORATORIES
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
HELENA LABORATORIES
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number864.7470
Classification Product Code
LCP  
Date Received04/15/1980
Decision Date 09/26/1980
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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