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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K823537
Device Name GLUCOSE REAGENT
Applicant
AC BIOCHEMICAL LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AC BIOCHEMICAL LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5860
Classification Product Code
FMF  
Date Received11/30/1982
Decision Date 04/06/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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