LAO

FDA Product Code LAO: Enzyme Immunoassay, Methotrexate

Leading manufacturers include Syva Co., Abbott Laboratories and ARK Diagnostics, Inc..

10
Total
10
Cleared
95d
Avg days
1978
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Enzyme Immunoassay, Methotrexate Devices (Product Code LAO)

10 devices
1–10 of 10
Cleared Feb 20, 2024
ONLINE TDM Methotrexate
K233454
Roche Diagnostics Operations
Toxicology · 123d
Cleared Dec 20, 2023
ARK Methotrexate II Assay
K232017
ARK Diagnostics, Inc.
Toxicology · 166d
Cleared Jul 14, 1993
TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II
K932615
Abbott Laboratories
Toxicology · 43d
Cleared Jan 30, 1989
ACA DU PONT METHOTREXATE (MTHO) METHOD
K884744
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 77d
Cleared Dec 22, 1983
EMIT & METHOFREXATE ASSAY
K833634
Syva Co.
Toxicology · 66d
Cleared Mar 10, 1983
TDX METHOTREXATE
K830398
Abbott Laboratories
Chemistry · 31d
Cleared Jun 09, 1981
EMIT-AND METHOTREXATE ASSAY
K811459
Syva Co.
Chemistry · 14d
Cleared Oct 10, 1978
EMIT METHATREXATE ASSAY
K781381
Dade Behring, Inc.
Toxicology · 60d

About Product Code LAO - Regulatory Context

510(k) Submission Activity

10 total 510(k) submissions under product code LAO since 1978, with 10 receiving FDA clearance (average review time: 95 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.