FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00
K Number: K091653
·
Decision Nov 2, 2009
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
17
Review Days
146
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Basic Information
- Device Name
- ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00
- K Number
- K091653
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3350
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ark Diagnostics, Inc.
- Date Received
- June 9, 2009
- Decision Date
- November 2, 2009
- Product Code
- ORI
- 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 |
|---|---|---|---|
| ORI | Levetiracetam Assay | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ORI), ordered by most recent decision date.
View allOther Clearances by Ark Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |