LIE — Reagent/Device, Inoculum Calibration Class II
FDA product code LIE covers "Reagent/Device, Inoculum Calibration", a Class II medical device regulated under 21 CFR 866.1640. Submissions are reviewed by the Microbiology panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LIE
- Device Class
- Class II
- Regulation Number
- 866.1640
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K221493 | beckman coulter | MicroScan Prompt Inoculation System-D | April 5, 2023 |
| K103456 | trek diagnostic systems | THE SENSITITRE AIM | June 22, 2011 |
| K110331 | trek diagnostic systems | SENSITITRE AIM (TM) | April 27, 2011 |
| K935566 | radiometer america | SENSI-CAL AMCO AEPA-1 | March 29, 1994 |
| K911059 | scientific device laboratory | TURBIDOMETRIC STANDARD | June 10, 1991 |
| K890339 | difco laboratories | DIFCO DIRECTOR INOCULATION SYSTEM | February 7, 1989 |
| K820299 | 3m | PROMPT INOCULATION SYSTEM | March 15, 1982 |