510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K944697Substantially Equivalent

Aura Flex Ft4 200 Test Pack, Ft4 Calibrator Pack

bioMerieux, Inc., Durham NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944697 is the FDA 510(k) clearance record for AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK, a class II device, cleared for Organon Teknika Corp. on under FDA product code CEC (Radioimmunoassay, Free Thyroxine). FDA records list 408 510(k) clearances for BIOMERIEUX, INC., from to . As of , FDA records show no recalls naming K944697.

Clearance record

Decision date
Received
(152 days to decision)
Product code
CEC Radioimmunoassay, Free Thyroxine
Regulation
21 CFR 862.1695
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Organon Teknika Corp. Treyburn 100 Akzo Ave., Durham NC
510(k) summary
Summary
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CEC, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260