ARK Diagnostics, Inc

FDA Filings

This page includes the latest FDA filings for ARK Diagnostics, Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
ARK Diagnostics, Inc.
ARK™ Fentanyl II Assay2020-02-26
ARK Diagnostics, Inc.
ARK Tramadol Assay2018-12-10
ARK Diagnostics, Inc.
ARK EDDP Assay2018-11-21
ARK Diagnostics, Inc.
ARK Fentanyl Assay2018-06-06
ARK Diagnostics, Inc.
ARK Methotrexate Assay2017-08-18
ARK DIAGNOSTICS, INC.
ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control2016-08-09
ARK DIAGNOSTICS,INC
ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN2011-10-18
ARK DIAGNOSTICS,INC
ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-02010-11-23
ARK DIAGNOSTICS,INC
ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL2010-10-29
ARK DIAGNOSTICS,INC
ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-00032009-12-09
ARK DIAGNOSTICS,INC
ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-002009-11-02
ARK DIAGNOSTICS,INC
TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-002009-04-16

Latest Premarket Applications

PMAManufacturerDevice NameDate

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
ARK™ Levetiracetam Assay
ARK DIAGNOSTICS INC2020-01-09
ARK™ Levetiracetam Control
ARK DIAGNOSTICS INC2020-01-09
ARK™ Levetiracetam Calibrator
ARK DIAGNOSTICS INC2020-01-09
ARK™ Pregabalin II Control
ARK DIAGNOSTICS INC2019-07-11
ARK™ Pregabalin II Calibrator
ARK DIAGNOSTICS INC2019-07-11
ARK™ Pregabalin II Assay
ARK DIAGNOSTICS INC2019-07-11
ARK™ EDDP Control (225/375)
ARK DIAGNOSTICS INC2019-02-21
ARK™ EDDP Control (75/125)
ARK DIAGNOSTICS INC2019-02-21
ARK™ EDDP 300 Cutoff Calibrator
ARK DIAGNOSTICS INC2019-02-21
ARK™ EDDP 100 Cutoff Calibrator
ARK DIAGNOSTICS INC2019-02-21
ARK™ EDDP Negative Calibrator
ARK DIAGNOSTICS INC2019-02-21
ARK™ EDDP Calibrator
ARK DIAGNOSTICS INC2019-02-21
ARK™ EDDP Assay - 500mL
ARK DIAGNOSTICS INC2019-02-21
ARK™ EDDP Assay - 115mL
ARK DIAGNOSTICS INC2019-02-21
ARK™ EDDP Assay
ARK DIAGNOSTICS INC2019-02-21
ARK™ Tramadol Control
ARK DIAGNOSTICS INC2019-02-21
ARK™ Tramadol Cutoff Calibrator
ARK DIAGNOSTICS INC2019-02-21
ARK™ Tramadol Negative Calibrator
ARK DIAGNOSTICS INC2019-02-21
ARK™ Tramadol Calibrator
ARK DIAGNOSTICS INC2019-02-21
ARK™ Tramadol Assay (500mL)
ARK DIAGNOSTICS INC2019-02-21
ARK™ Tramadol Assay (115mL)
ARK DIAGNOSTICS INC2019-02-21
ARK™ Tramadol Assay
ARK DIAGNOSTICS INC2019-02-21
ARK™ Methylphenidate Metabolite Assay
ARK DIAGNOSTICS INC2018-11-01
ARK™ Methylphenidate Metabolite Cutoff Calibrator
ARK DIAGNOSTICS INC2018-10-30
ARK™ Methylphenidate Negative Calibrator
ARK DIAGNOSTICS INC2018-10-30
ARK™ Methylphenidate Metabolite Control
ARK DIAGNOSTICS INC2018-10-30
ARK™ Methylphenidate Metabolite Calibrator
ARK DIAGNOSTICS INC2018-10-30
ARK™ Ethyl Glucuronide Control (750/1250)
ARK DIAGNOSTICS INC2018-10-15
ARK™ Ethyl Glucuronide Control (375/625)
ARK DIAGNOSTICS INC2018-10-15
ARK™ Ethyl Glucuronide 1000 Cutoff Calibrator
ARK DIAGNOSTICS INC2018-08-13
ARK™ Ethyl Glucuronide 500 Cutoff Calibrator
ARK DIAGNOSTICS INC2018-08-13
ARK™ Ethyl Glucuronide Negative Calibrator
ARK DIAGNOSTICS INC2018-08-13
ARK™ Ethyl Glucuronide Calibrator
ARK DIAGNOSTICS INC2018-08-13
ARK™ Ethyl Glucuronide Assay
ARK DIAGNOSTICS INC2018-08-13
ARK™ Ethyl Glucuronide Assay
ARK DIAGNOSTICS INC2018-08-13

Related Finance Registrations

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.