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510(k) K041928

HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B by Diagnostic Chemicals , Ltd. — Product Code LBS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2004
Date Received
July 19, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

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