Panels › Clinical Toxicology › Product code NWM · Class 2
Immunoassay, Anti-Seizure Drug
Regulation 862.3350
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in NWM
| Company | 510(k)s | Recalls |
|---|---|---|
| Ark Diagnostics, Inc. | 3 | 0 |
| Seradyn, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 5, 2021 | K201089 | ARK Lacosamide Assay Ark Diagnostics, Inc. | NWM |
| Dec 9, 2009 | K091884 | ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003 Ark Diagnostics, Inc. | NWM |
| Apr 16, 2009 | K083799 | TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00 Ark Diagnostics, Inc. | NWM |
| May 17, 2007 | K070645 | SERADYN QMS TOPIRAMATE Seradyn, Inc. | NWM |
| Nov 18, 2005 | K051211 | QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS Seradyn, Inc. | NWM |
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