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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alkaline Picrate, Colorimetry, Creatinine
510(k) Number K830556
Device Name CREATININE
Applicant
POINTE SCIENTIFIC, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
POINTE SCIENTIFIC, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1225
Classification Product Code
CGX  
Date Received02/23/1983
Decision Date 03/24/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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