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510(k) K123379

ABBOTT ARCHITECT FREE T4 by Abbott Laboratories — Product Code CEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2012
Date Received
November 1, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Free Thyroxine
Device Class
Class II
Regulation Number
862.1695
Review Panel
CH
Submission Type

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