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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Low Density, Lipoprotein
510(k) Number K041927
Device Name LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40
Applicant
Diagnostic Chemicals , Ltd.
16 Mccarville St.
Charlottetown, P.E.,  CA C1E 2A6
Applicant Contact NANCY OLSCAMP
Correspondent
Diagnostic Chemicals , Ltd.
16 Mccarville St.
Charlottetown, P.E.,  CA C1E 2A6
Correspondent Contact NANCY OLSCAMP
Regulation Number862.1475
Classification Product Code
MRR  
Date Received07/19/2004
Decision Date 11/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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