Panels › Microbiology › Product code LIE · Class 2
Reagent/Device, Inoculum Calibration
Regulation 866.1640
0510(k)s in 12 months (7 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in LIE
| Company | 510(k)s | Recalls |
|---|---|---|
| Beckman Coulter, Inc. | 1 | 1 |
| Trek Diagnostic Systems | 2 | 0 |
| 3M Company | 1 | 0 |
| Dade Behring, Inc. | 0 | 1 |
| Difco Laboratories, Inc. | 1 | 0 |
| Radiometer America, Inc. | 1 | 0 |
| Scientific Device Laboratory, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 5, 2023 | K221493 | MicroScan Prompt Inoculation System-D Beckman Coulter, Inc. | LIE |
| Jun 22, 2011 | K103456 | THE SENSITITRE AIM Trek Diagnostic Systems | LIE |
| Apr 27, 2011 | K110331 | SENSITITRE AIM (TM) Trek Diagnostic Systems, Ltd. | LIE |
| Mar 29, 1994 | K935566 | SENSI-CAL AMCO AEPA-1 Radiometer America, Inc. | LIE |
| Jun 10, 1991 | K911059 | TURBIDOMETRIC STANDARD Scientific Device Laboratory, Inc. | LIE |
| Feb 7, 1989 | K890339 | DIFCO DIRECTOR INOCULATION SYSTEM Difco Laboratories, Inc. | LIE |
| Mar 15, 1982 | K820299 | PROMPT INOCULATION SYSTEM 3M Company | LIE |
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