510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K140842Substantially Equivalent

Dimension Loci Free Thyroxine Flex Reagent Cartridge, Ft4l, Dimension Loci Thyroid Stimulating Hormone Flex Reagent Cart

Siemens Healthcare Diagnostics Inc., Newark DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140842 is the FDA 510(k) clearance record for DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART, a class II device, cleared for Siemens Healthcare Diagnostics, Inc. on under FDA product code CEC (Radioimmunoassay, Free Thyroxine). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics, Inc., from to . As of , FDA records show 2 recalls naming K140842.

Clearance record

Decision date
Received
(238 days to decision)
Product code
CEC Radioimmunoassay, Free Thyroxine
Regulation
21 CFR 862.1695
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Siemens Healthcare Diagnostics, Inc. P.O. Box 6101, Newark DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CEC

Trailing 12 months

FDA records hold no clearances under product code CEC in the trailing twelve months.

FDA records show no clearances under product code CEC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CEC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260