Immunoassay, Anti-Seizure Drug
The Immunoassay, Anti-Seizure Drug (product code NWM) is an in vitro diagnostic device used as an aid in the management of patients treated with anti-seizure medications, enabling monitoring of drug levels to guide therapeutic decisions. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 862.3350 within the Clinical Toxicology specialty. Third-party 510(k) review is available for this device type.
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Basic Information
- Product Code
- NWM
- Device Class
- FDA class 2
- Regulation Number
- 862.3350
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
Definition
To aid in management of patients treated with anti-seizure drug.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K201089 | ARK Lacosamide Assay | Aug 05, 2021 | Substantially Equivalent | Ark Diagnostics, Inc. |
| K091884 | ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003 | Dec 09, 2009 | Substantially Equivalent | Ark Diagnostics, Inc. |
| K083799 | TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00 | Apr 16, 2009 | Substantially Equivalent | Ark Diagnostics, Inc. |
| K070645 | SERADYN QMS TOPIRAMATE | May 17, 2007 | Substantially Equivalent | Seradyn, Inc. |
| K051211 | QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS | Nov 18, 2005 | Substantially Equivalent | Seradyn, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.