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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 K902543
Device Name ACID PHOSPHOTASE REAGENT TEST AND KIT
Applicant
Crestat Diagnostics, Inc.
P.O. Box 18225
Portland,  OR  97218
Applicant Contact KELTNER, M.D.
Correspondent
Crestat Diagnostics, Inc.
P.O. Box 18225
Portland,  OR  97218
Correspondent Contact KELTNER, M.D.
Regulation Number862.1020
Classification Product Code
CKB  
Date Received06/06/1990
Decision Date 09/07/1990
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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