# Ark Diagnostics, Inc.

- Location (FDA's records): Fremont, CA
- FDA decisions: 17 (2009–2024): 16 510(k) clearances and 1 De Novo grant
- Product codes: DJG (4), NWM (3), LAO (3), ORI (2), PUJ (1), DJR (1), ORH (1), POX (1), OTF (1)
- 510(k) review time since 2016: median 110 days, against 134 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 17 (7 its own); citations of its devices by later devices: 10 (7 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Seradyn, Inc.: 3 (https://510kreport.com/company/seradyn)
- Immunalysis Corporation: 2 (https://510kreport.com/company/immunalysis)
- Oxis Intl., Inc.: 2 (https://510kreport.com/company/oxis-intl)
- Microgenics Corp.: 1 (https://510kreport.com/company/microgenics)
- Syva Co., Dade Behring, Inc.: 1 (https://510kreport.com/company/syva-co-dade-behring)
- Abbott Laboratories: 1 (https://510kreport.com/company/abbott-laboratories)

## Firms that cite its devices most
- Shenzhen Superbio Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-superbio-technology)
- Roche Diagnostics Operations: 1 (https://510kreport.com/company/roche-diagnostics-operations)
- Lin-Zhi International, Inc.: 1 (https://510kreport.com/company/lin-zhi-international)

## Its most-cited devices
- K083799: Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate Control, Models 5015-0001-000, 5015-0002-00, 5015-0003-00 (2009), cited by 4
- K180427: ARK Fentanyl Assay (2018), cited by 2
- K111904: Ark Methotrexate Assay, Ark Methotrexate Calibrator, Ark Methotrexate Control, Ark Methotrexate Control (Calibration Ran (2011), cited by 2
- K091653: Ark Levetiracetam Assay, Ark Levetiracetam Calibrator and Ark Levetiracetam Control, Models 5024-0001-00, 5024-0002-00 (2009), cited by 1
- K182280: ARK Tramadol Assay (2018), cited by 1

## Recent decisions
- K232522: ARK Levetiracetam II Assay (Feb 27, 2024)
- K232017: ARK Methotrexate II Assay (Dec 20, 2023)
- K231752: ARK Hydrocodone Assay (Nov 9, 2023)
- K201089: ARK Lacosamide Assay (Aug 5, 2021)
- K200197: ARK Fentanyl II Assay (Feb 26, 2020)
- K182280: ARK Tramadol Assay (Dec 10, 2018)
- K182779: ARK EDDP Assay (Nov 21, 2018)
- K180427: ARK Fentanyl Assay (Jun 6, 2018)

Source page: https://510kreport.com/company/ark-diagnostics