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510(k) K092740

ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74 by Abbott Laboratories — Product Code CGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2010
Date Received
September 8, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Folic, Radioimmunoassay
Device Class
Class II
Regulation Number
862.1295
Review Panel
CH
Submission Type

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