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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 K980316
Device Name ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30
Applicant
DIAGNOSTIC CHEMICALS LTD.
16 FIRST ST.
WEST ROYALTY INDUSTRIAL PARK
CHARLOTTETOWN, P.E.I.,  CA C1E1B0
Applicant Contact KAREN CALLBECK
Correspondent
DIAGNOSTIC CHEMICALS LTD.
16 FIRST ST.
WEST ROYALTY INDUSTRIAL PARK
CHARLOTTETOWN, P.E.I.,  CA C1E1B0
Correspondent Contact KAREN CALLBECK
Regulation Number862.1050
Classification Product Code
CJE  
Date Received01/27/1998
Decision Date 02/12/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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