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510(k) K093631

B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644 by Siemens Healthcare Diagnostics — Product Code CDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2010
Date Received
November 24, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioassay, Vitamin B12
Device Class
Class II
Regulation Number
862.1810
Review Panel
CH
Submission Type

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