Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005755244

FEI Number

3005755244

Entity Name

ARK DIAGNOSTICS INC

City/State/Country

Fremont, CA, US

Establishment Address

48089 Fremont Blvd, Fremont, CA 94538, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

ARK Diagnostics Inc (Owner Number: 10027663)

Owner / Operator Contact Address

48089 Fremont Blvd, Fremont, CA 94538, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ARK EDDP Control ARK EDDP Calibrator ARK EDDP Assay ARK Lacosamide Assay; ARK Lacosamide Calibrator; ARK Lacosamide Control ARK Topiramate Control ARK Topiramate Assay ARK Topiramate Calibrator ARK Zonisamide Calibrator ARK Zonisamide Control ARK Zonisamide Assay ARK Ethyl Glucuronide II Assay ARK Ethyl Glucuronide Calibrator ARK Ethyl Glucuronide Assay ARK Ethyl Glucuronide Control ARK Fentanyl 0.5 ng/mL Assay/Calibrator/Control ARK Fentanyl II 0.5 ng/mL Assay ARK Levetiracetam II Assay ARK Levetiracetam II Control ARK Levetiracetam II Calibrator ARK Levetiracetam II Control ARK Levetiracetam II Assay ARK Levetiracetam II Calibrator ARK Hydrocodone Control ARK Hydrocodone Calibrator ARK Hydrocodone Assay ARK Ketamine Control ARK Ketamine Calibrator ARK Ketamine Assay ARK Ketamine II Assay ARK Ketamine II Control ARK Ketamine II Calibrator ARK Linezolid Assay ARK Linezolid Calibrator ARK Linezolid Control ARK Gabapentin Calibrator ARK Gabapentin Assay ARK Gabapentin Control ARK Efavirenz Assay ARK Efavirenz Control ARK Efavirenz Calibrator ARK Meperidine Calibrator ARK Meperidine Control ARK Meperidine Assay ARK HS Benzodiazepine II Control ARK HS Benzodiazepine II Calibrator ARK HS Benzodiazepine II Assay ARK Levetiracetam Control ARK Levetiracetam Calibrator ARK Levetiracetam Assay ARK Oxcarbazepine Metabolite Assay ARK Oxcarbazepine Metabolite Control ARK Oxcarbazepine Metabolite Calibrator ARK Pregabalin Urine Control ARK Pregabalin Urine Assay ARK Pregabalin Urine Calibrator ARK Lacosamide Calibrator ARK Lacosamide Assay ARK Lacosamide Control ARK Pregabalin II Calibrator ARK Pregabalin II Control ARK Pregabalin II Assay ARK Methylphenidate Metabolite Calibrator ARK Methylphenidate Metabolite Assay ARK Methylphenidate Metabolite Control

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2019-01-16
NWM	Immunoassay, Anti-Seizure Drug	Clinical Toxicology	Class 2	862.3350	2021-09-01
NWM	Immunoassay, Anti-Seizure Drug	Clinical Toxicology	Class 2	862.3350	2009-04-30
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2009-04-30
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2009-04-30
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2009-12-22
NWM	Immunoassay, Anti-Seizure Drug	Clinical Toxicology	Class 2	862.3350	2009-12-22
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2009-12-22
DMJ	Test Reagents For Ethyl Alcohol	Clinical Toxicology	Class 2	862.3040	2017-11-21
PVH	Test, Opiates, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3650	2018-04-11
ORI	Levetiracetam Assay	Clinical Toxicology	Class 2	862.3350	2024-07-10
ORI	Levetiracetam Assay	Clinical Toxicology	Class 2	862.3350	2022-05-26
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2024-07-23
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2019-06-17
LEH	Radioimmunoassay, Vancomycin	Clinical Toxicology	Class 2	862.3950	2018-05-23
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2010-11-30
OTF	Gabapentin Assay	Clinical Toxicology	Class 2	862.3350	2010-11-30
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2010-11-30
LCD	Enzyme Immunoassay, Gentamicin	Clinical Toxicology	Class 2	862.3450	2014-08-26
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2017-05-09
PUZ	Test, Benzodiazepine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3170	2023-11-14
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2009-11-19
ORI	Levetiracetam Assay	Clinical Toxicology	Class 2	862.3350	2009-11-19
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2009-11-19
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2016-08-18
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2016-08-18
POX	Enzyme Immunoassay, Oxcarbazepine Metabolite	Clinical Toxicology	Class 2	862.3645	2016-08-18
NWM	Immunoassay, Anti-Seizure Drug	Clinical Toxicology	Class 2	862.3350	2015-06-26
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2018-06-01

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ARK Diagnostics Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K131232	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)	2013-05-31
K780731	Vitek Systems, Inc.	LIDOCAINE CALIBRATOR KIT	1979-01-17
K833380	E.I. Dupont DE Nemours & Co., Inc.	LIDOAINE CALIBRATOR	1983-12-27
K153050	Co-Innovation Biotech Co., Ltd.	Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard	2016-04-26
K151478	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo CR3 Keyless Split Sample Cup	2015-07-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2013	Alere San Diego, Inc.	2	Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine.
Z-0042-2020	Roche Diagnostics Operations, Inc.	2	Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
Z-0043-2020	Roche Diagnostics Operations, Inc.	2	Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502
Z-0006-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0007-2010	Biosite Inc	2	Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005755244. Last updated year: 2026. Please use registration number 3005755244 when referencing this establishment in official correspondence.