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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pad, kelly
510(k) Number K841183
Device Name SODIUM CHLORIDE SOLUTION BLOOD CELL
Applicant
REAGENT LABORATORY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
REAGENT LABORATORY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4370
Classification Product Code
FNW  
Date Received03/20/1984
Decision Date 05/21/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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