510(k) K163359

Device: ARK Methotrexate Assay
Applicant: ARK Diagnostics, Inc.
510(k) number: K163359
Product code: LAO
Decision: Substantially Equivalent (SESE)
Decision date: 2017-08-18
Date received: 2016-11-30
Regulation: 510(k) Premarket Notification
Classification name: Enzyme Immunoassay, Methotrexate
Medical specialty: 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
Review panel: Toxicology
Device class: U
Clearance type: Special
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K233454	ONLINE TDM Methotrexate	Roche Diagnostics Operations	2024-02-20
K232017	ARK Methotrexate II Assay	Ark Diagnostics, Inc.	2023-12-20
K111904	ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN	Ark Diagnostics, Inc.	2011-10-18
K932615	TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II	Abbott Laboratories	1993-07-14
K884744	ACA DU PONT METHOTREXATE (MTHO) METHOD	E.I. Dupont DE Nemours & Co., Inc.	1989-01-30
K833634	EMIT & METHOFREXATE ASSAY	Syva Co.	1983-12-22
K830398	TDX METHOTREXATE	Abbott Laboratories	1983-03-10
K811459	EMIT-AND METHOTREXATE ASSAY	Syva Co.	1981-06-09
K781381	EMIT METHATREXATE ASSAY	Dade Behring, Inc.	1978-10-10

summary

Decision Summary