510(k) K091949 ยท LTT Panels, Test, Susceptibility, Antimicrobial
MICROSCAN MICROSTREP PLUS, MODEL B1027-201
| Applicant | Siemens Healthcare Diagnostics, West Sacramento CA, US |
| Decision | Substantially Equivalent, Jan 26, 2010 |
| Received | Jul 1, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091949
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2015 | Beckman Coulter Inc. MICroSTREP plus 1 Panel, Part No. B1027-201
Product Usage:
MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of c Terminated |
LTT | None listed |
| Oct 7, 2015 | Beckman Coulter Inc. MICroSTREP plus 2 Panel, Part No. B1027-202
Product Usage:
MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of c Terminated |
LTT | None listed |
| May 8, 2013 | Siemens Healthcare Diagnostics, Inc. Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels.
.MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenteroco Terminated |
LTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.