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510(k) K014103

SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR by Beckman Coulter, Inc. — Product Code MRR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2002
Date Received
December 13, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Low Density, Lipoprotein
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

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