ClearanceBrief
Product code LAO ยท Class U

Enzyme Immunoassay, Methotrexate

0510(k)s in 12 months (10 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
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Top companies in LAO

Company510(k)sRecalls
Ark Diagnostics, Inc.30
Abbott Laboratories20
Syva Co.20
Abbott Diagnostic International, Ltd.01
Dade Behring, Inc.10
E.I. Dupont DE Nemours & Co., Inc.10
Roche Diagnostics Operations10
Siemens Healthcare Diagnostics, Inc.01
Decided510(k)Device and applicantCode
Feb 20, 2024K233454ONLINE TDM Methotrexate
Roche Diagnostics Operations
LAO
Dec 20, 2023K232017ARK Methotrexate II Assay
Ark Diagnostics, Inc.
LAO
Aug 18, 2017K163359ARK Methotrexate Assay
Ark Diagnostics, Inc.
LAO
Oct 18, 2011K111904ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN
Ark Diagnostics, Inc.
LAO
Jul 14, 1993K932615TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II
Abbott Laboratories
LAO
Jan 30, 1989K884744ACA DU PONT METHOTREXATE (MTHO) METHOD
E.I. Dupont DE Nemours & Co., Inc.
LAO
Dec 22, 1983K833634EMIT & METHOFREXATE ASSAY
Syva Co.
LAO
Mar 10, 1983K830398TDX METHOTREXATE
Abbott Laboratories
LAO
Jun 9, 1981K811459EMIT-AND METHOTREXATE ASSAY
Syva Co.
LAO
Oct 10, 1978K781381EMIT METHATREXATE ASSAY
Dade Behring, Inc.
LAO

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