FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARK Lacosamide Assay
K Number: K201089
·
Decision Aug 5, 2021
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
4
Applicant Total
9
Review Days
469
Basic Information
- Device Name
- ARK Lacosamide Assay
- K Number
- K201089
- 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
- April 23, 2020
- Decision Date
- August 5, 2021
- Product Code
- NWM
- 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 |
|---|---|---|---|
| NWM | Immunoassay, Anti-Seizure Drug | FDA class 2 | Clinical Toxicology |
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