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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Phosphomolybdate (Colorimetric), Inorganic Phosphorus
510(k) Number K843030
Device Name INORGANIC PHOSPHORUS ASSAY KIT
Applicant
Diagnostic Chemicals, Ltd. (Usa)
4 Newland Crescent
Charlottetown
Canada, 
Correspondent
Diagnostic Chemicals, Ltd. (Usa)
4 Newland Crescent
Charlottetown
Canada, 
Regulation Number862.1580
Classification Product Code
CEO  
Date Received08/01/1984
Decision Date 08/27/1984
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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