Panels › Clinical Toxicology › Product code OTF · Class 2
Gabapentin Assay
Regulation 862.3350
0510(k)s in 12 months (1 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OTF
| Company | 510(k)s | Recalls |
|---|---|---|
| Ark Diagnostics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 23, 2010 | K101574 | ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0 Ark Diagnostics, Inc. | OTF |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.