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510(k) K121314

ARCHITECT B12 by Abbott Laboratories — Product Code CDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2012
Date Received
May 2, 2012
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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