510(k) K051211
- Device
- QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS
- Applicant
- SERADYN INC.
- 510(k) number
- K051211
- Product code
- NWM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-11-18
- Date received
- 2005-05-11
- Regulation
- 862.3350
- Classification name
- Immunoassay, Anti-seizure Drug
- Medical specialty
- Toxicology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JACK ROGERS
- Address
- 7998 Georgetown Rd. Suite 1000 Indianapolis IN US 46268 46268
FDA Registration Numbers#
- 3010939897
- 3005755244
Source Documents#
Other 510(k) Records For Product Code NWM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201089 | ARK Lacosamide Assay | Ark Diagnostics, Inc. | 2021-08-05 |
| K091884 | ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003 | Ark Diagnostics, Inc. | 2009-12-09 |
| K083799 | TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00 | Ark Diagnostics, Inc. | 2009-04-16 |
| K070645 | SERADYN QMS TOPIRAMATE | Seradyn, Inc. | 2007-05-17 |
Legacy Summary#
summary
FDA Review#
Decision Summary