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510(k) K020724

DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131 by Dade Behring, Inc. — Product Code MRR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2002
Date Received
March 6, 2002
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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