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
K932615Substantially Equivalent

Tdx(r)/tdx(r)flx(r)mehtotrexate II

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

K932615 is the FDA 510(k) clearance record for TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II, cleared for Abbott Laboratories on under FDA product code LAO (Enzyme Immunoassay, Methotrexate). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show one recall naming K932615.

Clearance record

Decision date
Received
(43 days to decision)
Product code
LAO Enzyme Immunoassay, Methotrexate
Device class
Unclassified
Review panel
Unknown
Applicant
Abbott Laboratories Abbott Labs, Abbott Park IL
510(k) summary
Summary
Third party review
No

Clearances, product code LAO

Trailing 12 months

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

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