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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 K902172
Device Name COULTER CREATININE REAGENT
Applicant
Coulter Corp.
745 W. 83rd St.
Hialeah,  FL  33014
Applicant Contact BENITA BRADFORD
Correspondent
Coulter Corp.
745 W. 83rd St.
Hialeah,  FL  33014
Correspondent Contact BENITA BRADFORD
Regulation Number862.1225
Classification Product Code
CGX  
Date Received05/14/1990
Decision Date 06/28/1990
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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