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510(k) K110579

ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS by Abbott Laboratories — Product Code CDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2011
Date Received
March 1, 2011
Clearance Type
Traditional
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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