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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
510(k) Number K900216
Device Name COULTER ALP (ALK PHOS) REAGENT
Applicant
Coulter Corp.
745 W. 83rd St.
Hialeah,  FL  33014
Applicant Contact A RICHARDSON-JONES
Correspondent
Coulter Corp.
745 W. 83rd St.
Hialeah,  FL  33014
Correspondent Contact A RICHARDSON-JONES
Regulation Number862.1050
Classification Product Code
CJE  
Date Received01/17/1990
Decision Date 02/08/1990
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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