Ark Diagnostics, Inc.
Ark Diagnostics, Inc. appears in FDA public data with 0 recalls, 17 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on February 27, 2024.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 17
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K232522 | ARK Levetiracetam II Assay | February 27, 2024 |
| K232017 | ARK Methotrexate II Assay | December 20, 2023 |
| K231752 | ARK Hydrocodone Assay | November 9, 2023 |
| K201089 | ARK Lacosamide Assay | August 5, 2021 |
| K200197 | ARK Fentanyl II Assay | February 26, 2020 |
| K182280 | ARK Tramadol Assay | December 10, 2018 |
| K182779 | ARK EDDP Assay | November 21, 2018 |
| K180427 | ARK Fentanyl Assay | June 6, 2018 |
| K163359 | ARK Methotrexate Assay | August 18, 2017 |
| DEN160033 | ARK Voriconazole II Assay Test System | May 5, 2017 |
| K153596 | ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metab | August 9, 2016 |
| K111904 | ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONT | October 18, 2011 |
| K101574 | ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025- | November 23, 2010 |
| K101305 | ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL | October 29, 2010 |
| K091884 | ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 502 | December 9, 2009 |
| K091653 | ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-000 | November 2, 2009 |
| K083799 | TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0 | April 16, 2009 |