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510(k) K083373

IMMULITE 2000 FREE T4 by Siemens Healthcare Diagnostics, Inc. — Product Code CEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2009
Date Received
November 14, 2008
Clearance Type
Traditional
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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  • K152422 — FREND™ Free T4 Test System (February 17, 2016)
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