FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARK Tramadol Assay
K Number: K182280
·
Decision Dec 10, 2018
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
214
Applicant Total
17
Review Days
110
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Basic Information
- Device Name
- ARK Tramadol Assay
- K Number
- K182280
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3650
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ark Diagnostics, Inc.
- Date Received
- August 22, 2018
- Decision Date
- December 10, 2018
- Product Code
- DJG
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | FDA class 2 | Clinical Toxicology |
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|---|---|---|---|
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| K231752 | ARK Hydrocodone Assay | Nov 9, 2023 | Substantially Equivalent |
| K201089 | ARK Lacosamide Assay | Aug 5, 2021 | Substantially Equivalent |
| K200197 | ARK Fentanyl II Assay | Feb 26, 2020 | Substantially Equivalent |
| K182779 | ARK EDDP Assay | Nov 21, 2018 | Substantially Equivalent |
| K180427 | ARK Fentanyl Assay | Jun 6, 2018 | Substantially Equivalent |
| K163359 | ARK Methotrexate Assay | Aug 18, 2017 | Substantially Equivalent |
| DEN160033 | ARK Voriconazole II Assay Test System | May 5, 2017 | Unknown |
| K153596 | ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control | Aug 9, 2016 | Substantially Equivalent |