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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ldl & Vldl Precipitation, Hdl
510(k) Number K980772
Device Name HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51
Applicant
Diagnostic Chemicals , Ltd.
West Royalty Industrial Park,
Charlottetown, P.E.I.,  CA C1E 2A6
Applicant Contact KAREN CALLBECK
Correspondent
Diagnostic Chemicals , Ltd.
West Royalty Industrial Park,
Charlottetown, P.E.I.,  CA C1E 2A6
Correspondent Contact KAREN CALLBECK
Regulation Number862.1475
Classification Product Code
LBR  
Date Received02/20/1998
Decision Date 04/27/1998
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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