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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2020 | Beckman Coulter Inc. Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI: 15099590659561 - Product Usage: The Prompt Inoculation System-D is used to standardize inocula for microdilution a Terminated |
LIE | K820299 |
| Dec 5, 2006 | Dade Behring, Inc. Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D; Terminated |
LIE | K820299 |
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