Chrysalis Intelligence · Sponsors · Ark Diagnostics, Inc.

Ark Diagnostics, Inc.

Fremont, CA, US · 5 510(k) clearances

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals

Total clearances

5

2020-02-26 → 2024-02-27

Last 12 months

0

Product codes

4

Most recent

2024-02-27

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
DJG	Enzyme Immunoassay, Opiates	Class II	Clinical Toxicology	2	2023-11-09
ORI	Levetiracetam Assay	Class II	Clinical Toxicology	1	2024-02-27
LAO	Enzyme Immunoassay, Methotrexate	Unclassified	Unknown	1	2023-12-20
NWM	Immunoassay, Anti-Seizure Drug	Class II	Clinical Toxicology	1	2021-08-05

Filings

All 510(k) clearances (5)

Date	K-number	Device	Code	Class	Specialty
2024-02-27	K232522	ARK Levetiracetam II Assay	ORI	Class II	Clinical Toxicology
2023-12-20	K232017	ARK Methotrexate II Assay	LAO	Unclassified	Unknown
2023-11-09	K231752	ARK Hydrocodone Assay	DJG	Class II	Clinical Toxicology
2021-08-05	K201089	ARK Lacosamide Assay	NWM	Class II	Clinical Toxicology
2020-02-26	K200197	ARK Fentanyl II Assay	DJG	Class II	Clinical Toxicology