510(k) K820299 ยท LIE Reagent/Device, Inoculum Calibration
PROMPT INOCULATION SYSTEM
| Applicant | 3M Company, White City OR, US |
| Decision | Substantially Equivalent, Mar 15, 1982 |
| Received | Feb 4, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K820299
| 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 | None listed |
| Dec 5, 2006 | Dade Behring, Inc. Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D; Terminated |
LIE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.