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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 K932766
Device Name HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)
Applicant
Diagnostic Chemicals, Ltd. (Usa)
16 First St.
West Royalty Industrial Park
Charlottestown,Pei,Canada,  CA C1E 1B0
Applicant Contact KAREN M CALLBECK
Correspondent
Diagnostic Chemicals, Ltd. (Usa)
16 First St.
West Royalty Industrial Park
Charlottestown,Pei,Canada,  CA C1E 1B0
Correspondent Contact KAREN M CALLBECK
Regulation Number862.1475
Classification Product Code
LBR  
Date Received06/08/1993
Decision Date 12/10/1993
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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