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510(k) K043264

LDL-EX SEIKEN ASSAY KIT by Denka Seiken Co., Ltd. — Product Code MRR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2005
Date Received
November 24, 2004
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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