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510(k) K170160

Abbott ARCHITECT Free T3 by Abbott Laboratories — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2017
Date Received
January 18, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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