510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K946199Substantially Equivalent

Auraflex(r) Estradiol

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

K946199 is the FDA 510(k) clearance record for AURAFLEX(R) ESTRADIOL, a class I device, cleared for Organon Teknika Corp. on under FDA product code CHP (Radioimmunoassay, Estradiol). FDA records list 408 510(k) clearances for BIOMERIEUX, INC., from to . As of , FDA records show no recalls naming K946199.

Clearance record

Decision date
Received
(104 days to decision)
Product code
CHP Radioimmunoassay, Estradiol
Regulation
21 CFR 862.1260
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Organon Teknika Corp. 100 Akzo Ave., Durham NC
510(k) summary
Summary
Third party review
No

Clearances, product code CHP

Trailing 12 months

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

FDA records show no clearances under product code CHP in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CHP, 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