510(k) K993421 ยท MDB System, Blood Culturing
BACT/ALERT SN
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Dec 14, 1999 |
| Received | Oct 12, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993421
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 24, 2015 | bioMerieux, Inc. BacT/ALERT SN, bioMrieux, Inc.
Product Usage:
BacT/ALERT Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerob Terminated |
MDB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.