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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 K843377
Device Name CREATININE ASSAY KIT
Applicant
Diagnostic Chemicals, Ltd. (Usa)
4 Newland Crescent
Charlottetown
Canada, 
Correspondent
Diagnostic Chemicals, Ltd. (Usa)
4 Newland Crescent
Charlottetown
Canada, 
Regulation Number862.1225
Classification Product Code
CGX  
Date Received08/28/1984
Decision Date 09/28/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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