510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131244Substantially Equivalent

Elecsys Ft4 II Assay, Elecsys Ft4 II Calset

Roche Diagnostics GmbH, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131244 is the FDA 510(k) clearance record for ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET, a class II device, cleared for Roche Diagnostics on under FDA product code CEC (Radioimmunoassay, Free Thyroxine). FDA records list 465 510(k) clearances for Roche Diagnostics, from to . As of , FDA records show no recalls naming K131244.

Clearance record

Decision date
Received
(271 days to decision)
Product code
CEC Radioimmunoassay, Free Thyroxine
Regulation
21 CFR 862.1695
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Roche Diagnostics 9115 Hague Rd., Indianapolis IN
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