Product code LAO— Unknown

ACA DU PONT METHOTREXATE (MTHO) METHOD

Classification name: Enzyme Immunoassay, Methotrexate
Device class: Unclassified
Advisory panel: Unknown
Total cleared: 10
First cleared: 1978-10-10
Most recent: 2024-02-20

Market context for product code LAO

FDA has cleared 10 devices under product code LAO between 1978 and 2024, filed by 6 applicant companies. No FDA device recalls reference this product code.

Clearances per year

20241 clearance
20231 clearance
20171 clearance
20111 clearance
19931 clearance
19891 clearance
19832 clearances
19811 clearance
19781 clearance

Top applicants under product code LAO

Ark Diagnostics, Inc.3 clearances
Syva Co.2 clearances
Abbott Laboratories2 clearances
Roche Diagnostics Operations1 clearance
E.I. Dupont DE Nemours & Co., Inc.1 clearance
Dade Behring, Inc.1 clearance

Recent clearances under product code LAO

K233454 — ONLINE TDM MethotrexateRoche Diagnostics Operations·2024-02-20
K232017 — ARK Methotrexate II AssayArk Diagnostics, Inc.·2023-12-20
K163359 — ARK Methotrexate AssayArk Diagnostics, Inc.·2017-08-18
K111904 — ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RANArk Diagnostics, Inc.·2011-10-18
K932615 — TDX(R)/TDX(R)FLX(R)MEHTOTREXATE IIAbbott Laboratories·1993-07-14
K884744 — ACA DU PONT METHOTREXATE (MTHO) METHODE.I. Dupont DE Nemours & Co., Inc.·1989-01-30
K833634 — EMIT & METHOFREXATE ASSAYSyva Co.·1983-12-22
K830398 — TDX METHOTREXATEAbbott Laboratories·1983-03-10
K811459 — EMIT-AND METHOTREXATE ASSAYSyva Co.·1981-06-09
K781381 — EMIT METHATREXATE ASSAYDade Behring, Inc.·1978-10-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.