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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 K880795
Device Name RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF.
Applicant
Trace America, Inc.
P.O. Box 45-1835
Miami,  FL  33245
Applicant Contact RAY LOPEZ
Correspondent
Trace America, Inc.
P.O. Box 45-1835
Miami,  FL  33245
Correspondent Contact RAY LOPEZ
Regulation Number862.1050
Classification Product Code
CJE  
Date Received02/26/1988
Decision Date 04/18/1988
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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