Panels › Microbiology › Product code LIO · Class 1
Device, Specimen Collection
Regulation 866.2900
0510(k)s in 12 months (63 all time)
0recalls in 12 months (3 all time)
1recalls that name a 510(k)
Top companies in LIO
| Company | 510(k)s | Recalls |
|---|---|---|
| Remel Co. | 5 | 1 |
| Pro-Lab Diagnostics | 4 | 0 |
| Medical Laboratory Automation Systems, Inc. | 3 | 0 |
| Sage Products, Inc. | 3 | 0 |
| Bio-Rad | 2 | 0 |
| Kallestad Diag, A Div. of Erbamont, Inc. | 2 | 0 |
| Medical Packaging Corp. | 2 | 0 |
| Medical Wire & Equipment Company (Bath), Ltd. | 2 | 0 |
| Ncs Diagnostics, Inc. | 2 | 0 |
| Para Scientific Co. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2025 | Hologic, Inc. The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The Collection Tube (PN: 71550-001) is manufactured by a third-party sup Open, Classified |
LIO | K900225 |
| Jul 14, 2020 | Thomas Scientific Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection. Open, Classified |
LIO | None listed |
| Aug 18, 2009 | Remel, Inc Remel BactiSwab NPG Collection and Transport System, Sterile, 100 swab units/box, Catalog 12300. The firm name on the label is Remel, Lenexa, KS.
Collection and transportation of clinical specimens Terminated |
LIO | None listed |
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