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ARK DIAGNOSTICS INC

Matched from indexed company URL: ARK DIAGNOSTICS,INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30057552443005755244ARK DIAGNOSTICS INC1N2026-01-0148089 Fremont Blvd Fremont CA US 94538

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00812101031599ARK™ Ketamine II Assay - The ARK Ketamine II Assay is an immunoassay intended for the qualitative detection and/or semi-quantitative estimation of ketamine in human urine at cutoffs of 50 ng/mL and 100 ng/mL.5102706270customersupport@ark-tdm.com
00812101031605ARK™ Ketamine II Assay - The ARK Ketamine II Assay is an immunoassay intended for the qualitative detection and/or semi-quantitative estimation of ketamine in human urine at cutoffs of 50 ng/mL and 100 ng/mL.5102706270customersupport@ark-tdm.com
00812101031612ARK™ Ketamine II Assay - The ARK Ketamine II Assay is an immunoassay intended for the qualitative detection and/or semi-quantitative estimation of ketamine in human urine at cutoffs of 50 ng/mL and 100 ng/mL.5102706270customersupport@ark-tdm.com
00812101031629ARK™ Ketamine II Calibrator - The ARK Ketamine II Calibrator is intended for use in calibration of the ARK Ketamine II Assay.5102706270customersupport@ark-tdm.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
959951627689118K232522ARK Levetiracetam II AssayORI2024-02-27
959951480435104K232017ARK Methotrexate II AssayLAO2023-12-20
959951706414982K231752ARK Hydrocodone AssayDJG2023-11-09
959951308453116K201089ARK Lacosamide AssayNWM2021-08-05
959951376352262K200197ARK Fentanyl II AssayDJG2020-02-26
959951684484016K182779ARK EDDP AssayDJR2018-11-21
959951357383437K182280ARK Tramadol AssayDJG2018-12-10
959951508381253K180427ARK Fentanyl AssayDJG2018-06-06
959951855655044K153596ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite ControlPOX2016-08-09
959951454645027K111904ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RANLAO2011-10-18
959951594724337K101574ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0OTF2010-11-23
959951545984549K101305ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROLORH2010-10-29
959951021516410K091884ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003NWM2009-12-09
959951396407832K091653ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00ORI2009-11-02
959951967475494K083799TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00NWM2009-04-16
959951107436605DEN160033ARK Voriconazole II Assay Test SystemPUJ2017-05-05
959951009768869
959951045653042
959951219062624
959951245061582
959951283574575
959951334917932
959951436153089
959951537138786
959951601761784
959951696333212
959952023335067

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DJG42023-11-09
NWM32021-08-05
ORI22024-02-27
LAO22023-12-20
DJR12018-11-21
PUJ12017-05-05
POX12016-08-09
OTF12010-11-23
ORH12010-10-29

PMN#

GUDID#

169 records. Showing 1-40. Next