Panels › Clinical Toxicology › Product code ORH · Class 2
Lamotrigine Assay
Regulation 862.3350
0510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in ORH
| Company | 510(k)s | Recalls |
|---|---|---|
| Ark Diagnostics, Inc. | 1 | 0 |
| Seradyn, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 29, 2010 | K101305 | ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL Ark Diagnostics, Inc. | ORH |
| Jan 12, 2007 | K062966 | QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS Seradyn, Inc. | ORH |
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