FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN
K Number: K111904
·
Decision Oct 18, 2011
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
9
Applicant Total
17
Review Days
105
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Basic Information
- Device Name
- ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN
- K Number
- K111904
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ark Diagnostics, Inc.
- Date Received
- July 5, 2011
- Decision Date
- October 18, 2011
- Product Code
- LAO
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LAO | Enzyme Immunoassay, Methotrexate | FDA unclassified | Unknown |
Similar 510(k) Clearances
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TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II
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ACA DU PONT METHOTREXATE (MTHO) METHOD
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EMIT & METHOFREXATE ASSAY
FDA 510(k)
FDA Unclassified
·Unknown
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|---|---|---|---|
| K232522 | ARK Levetiracetam II Assay | Feb 27, 2024 | Substantially Equivalent |
| K232017 | ARK Methotrexate II Assay | Dec 20, 2023 | Substantially Equivalent |
| 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 |
| K182280 | ARK Tramadol Assay | Dec 10, 2018 | 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 |