Reagent/Device, Inoculum Calibration
FDA product code LIE · Class II (moderate risk) · 21 CFR 866.1640 · Microbiology
7510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221493 | MicroScan Prompt Inoculation System-DLIE · Traditional | Beckman Coulter, Inc. | 04/05/2023SE |
| K103456 | The Sensititre AimLIE · Traditional | Trek Diagnostic Systems | 06/22/2011SE |
| K110331 | Sensititre Aim (TM)LIE · Traditional | Trek Diagnostic Systems, Ltd. | 04/27/2011SE |
| K935566 | Sensi-Cal Amco AEPA-1LIE · Traditional | Radiometer America, Inc. | 03/29/1994SE |
| K911059 | Turbidometric StandardLIE · Traditional | Scientific Device Laboratory, Inc. | 06/10/1991SE |
| K890339 | Difco Director Inoculation SystemLIE · Traditional | Difco Laboratories, Inc. | 02/07/1989SE |
| K820299 | Prompt Inoculation SystemLIE · Traditional | 3M Company | 03/15/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1674-2020 Class II | Beckman Coulter MicroScan PROMPT Inoculation System-D, Catalog Number B1026-10D, UDI:…Due to customer reports it has been determined that the inoculation system contains the incorrect prompt… | Beckman Coulter Inc. | 12/13/2019Terminated |
| Z-0247-2007 | Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D;Product does not meet performance specifications through its standardized inocula for MicroScan Dried… | Dade Behring, Inc. | 09/27/2006Terminated |