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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, Thymolphthale Inmonophosphate
510(k) Number K843380
Device Name ACID PHOSPHATASE ASSAY KIT
Applicant
Diagnostic Chemicals, Ltd. (Usa)
4 Newland Crescent
Charlottetown
Canada, 
Correspondent
Diagnostic Chemicals, Ltd. (Usa)
4 Newland Crescent
Charlottetown
Canada, 
Regulation Number862.1020
Classification Product Code
CKE  
Date Received08/28/1984
Decision Date 09/20/1984
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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