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510(k) K050632

ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY by Bayer Healthcare, LLC — Product Code LBS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2005
Date Received
March 9, 2005
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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  • K100550 — POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-C (September 28, 2010)
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