FDA.reportPublic FDA data

510(k) K781381

Device
Emit Methatrexate Assay
Applicant
DADE BEHRING, INC.
510(k) number
K781381
Product code
LAO
Decision
Substantially Equivalent (SESE)
Decision date
1978-10-10
Date received
1978-08-11
Classification name
Enzyme Immunoassay, Methotrexate
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
YUK-TING LEWIS
Address
P.O. Box 6101 Newark DE US 19714 19714

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LAO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K233454ONLINE TDM MethotrexateRoche Diagnostics Operations2024-02-20
K232017ARK Methotrexate II AssayArk Diagnostics, Inc.2023-12-20
K163359ARK Methotrexate AssayArk Diagnostics, Inc.2017-08-18
K111904ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RANArk Diagnostics, Inc.2011-10-18
K932615TDX(R)/TDX(R)FLX(R)MEHTOTREXATE IIAbbott Laboratories1993-07-14
K884744ACA DU PONT METHOTREXATE (MTHO) METHODE.I. Dupont DE Nemours & Co., Inc.1989-01-30
K833634EMIT & METHOFREXATE ASSAYSyva Co.1983-12-22
K830398TDX METHOTREXATEAbbott Laboratories1983-03-10
K811459EMIT-AND METHOTREXATE ASSAYSyva Co.1981-06-09