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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid Phosphatase, Naphthyl Phosphate
510(k) Number K880798
Device Name ACID PHOSPHATASE REAGENT
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 Number862.1020
Classification Product Code
CKB  
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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