LIOClass I
Device, Specimen Collection
21 CFR 866.2900 / Microbiology
LIO is the FDA product code for Device, Specimen Collection, a class I device type, regulated under 21 CFR 866.2900. As of , FDA records hold 63 510(k) clearances under this code, the most recent dated , and 3 recalls.
Classification record
- Product code
- LIO
- Device name
- Device, Specimen Collection
- Regulation
- 21 CFR 866.2900
- Device class
- Class I
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 63
- Ingested recalls
- 3
Clearances, product code LIO
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1983 | 2 |
| 1984 | 5 |
| 1985 | 3 |
| 1986 | 3 |
| 1987 | 6 |
| 1988 | 4 |
| 1989 | 2 |
| 1990 | 6 |
| 1991 | 3 |
| 1992 | 7 |
| 1993 | 4 |
| 1995 | 2 |
| 1996 | 5 |
| 1998 | 1 |
| 1999 | 1 |
| 2001 | 2 |
| 2007 | 1 |
| 2008 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2024 | 1 |
Applicants with the most clearances
Product code LIO| Applicant | Clearances |
|---|---|
| Remel Inc | 5 |
| Pro-Lab Diagnostics | 4 |
| Medical Laboratory Automation Systems, Inc. | 3 |
| Sage Products LLC | 3 |
| Bio-Rad | 2 |
| Kallestad Diag, A Div. of Erbamont, Inc. | 2 |
| Medical Packaging Corporation | 2 |
| Medical Wire & Equipment Company (Bath), Ltd. | 2 |
| Ncs Diagnostics, Inc. | 2 |
| Para Scientific Co. | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.