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510(k) K984108

ABBOTT ARCHITECT B12 by Abbott Laboratories — Product Code LIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1999
Date Received
November 17, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioassay, Intrinsic Factor Blocking Antibody
Device Class
Class II
Regulation Number
862.1810
Review Panel
CH
Submission Type

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