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510(k) K140842

DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART by Siemens Healthcare Diagnostics, Inc. — Product Code CEC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 26, 2014
Date Received: April 2, 2014
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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