LIE
7 FDA 510(k) clearances · Product code
91 daysmedian time to decision
317 days90th percentile
7clearances measured
FDA profile
- Official device name
- Reagent/Device, Inoculum Calibration
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MicroScan Prompt Inoculation System-D (K221493) | Beckman Coulter, Inc. | 2023-04-05 |
| THE SENSITITRE AIM (K103456) | Trek Diagnostic Systems | 2011-06-22 |
| SENSITITRE AIM (TM) (K110331) | Trek Diagnostic Systems, Ltd. | 2011-04-27 |
| SENSI-CAL AMCO AEPA-1 (K935566) | Radiometer America, Inc. | 1994-03-29 |
| TURBIDOMETRIC STANDARD (K911059) | Scientific Device Laboratory, Inc. | 1991-06-10 |
| DIFCO DIRECTOR INOCULATION SYSTEM (K890339) | Difco Laboratories, Inc. | 1989-02-07 |
| PROMPT INOCULATION SYSTEM (K820299) | 3M Company | 1982-03-15 |
Track LIE automatically
Every clearance here is in the API, with alerts when new ones post.