510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K940817Substantially Equivalent

Tdx(r)/tdxflx(r) Fetal Lung Maturity II

Abbott Medical, Abbott Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940817 is the FDA 510(k) clearance record for TDX(R)/TDXFLX(R) FETAL LUNG MATURITY II, a class II device, cleared for Abbott Laboratories on under FDA product code JHF (Colorimetric Method, Lecithin/Sphingomyelin Ratio). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K940817.

Clearance record

Decision date
Received
(351 days to decision)
Product code
JHF Colorimetric Method, Lecithin/Sphingomyelin Ratio
Regulation
21 CFR 862.1455
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Abbott Laboratories Dept: 09v8 Bldg: Ap5-2, Abbott Park IL
510(k) summary
Summary
Third party review
No

Clearances, product code JHF

Trailing 12 months

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

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