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510(k) K983440

ABBOTT ARCHITECT TOTAL T4 by Abbott Laboratories — Product Code KLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 1998
Date Received
September 29, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Device Class
Class II
Regulation Number
862.1700
Review Panel
CH
Submission Type

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