Home / 510(k) Clearances / K073604

510(k) K073604

DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD by Dade Behring, Inc. — Product Code CEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2008
Date Received
December 21, 2007
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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Other clearances for product code CEC

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  • K152422 — FREND™ Free T4 Test System (February 17, 2016)
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  • K140842 — DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYRO (November 26, 2014)
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