510(k) K050002 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
VITEK 2 COMPACT
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Feb 17, 2005 |
| Received | Jan 3, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050002
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2021 | Biomerieux Inc VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 i Terminated |
LON | None listed |
| Jan 28, 2021 | Biomerieux Inc VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). V Terminated |
LON | None listed |
| Nov 13, 2018 | bioMerieux, Inc. VITEK 2 Systems Software Version 9.01 Update Kit. Terminated |
LON | None listed |
| Jul 12, 2017 | Biomerieux Inc VITEK 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast. Terminated |
LON | None listed |
| Jul 12, 2017 | Biomerieux Inc VITEK 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17630R (industry) software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing Terminated |
LON | None listed |
| Mar 25, 2013 | Biomerieux Inc VITEK 2 Compact computer system when equipped with the following Hewlett-Packard PC models:
(1) dc7100 8-port, Cat. #W0441;
(2) dc7100 8-port (refurbished), Cat. #W0441R;
(3) dc7700 8-port, Cat. #W Terminated |
LTW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.