Panels › Clinical Toxicology › Product code ORI · Class 2
Levetiracetam 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 ORI
| Company | 510(k)s | Recalls |
|---|---|---|
| Ark Diagnostics, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 27, 2024 | K232522 | ARK Levetiracetam II Assay Ark Diagnostics, Inc. | ORI |
| Nov 2, 2009 | K091653 | ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00 Ark Diagnostics, Inc. | ORI |
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