510(k) K121002 ยท JWY Manual Antimicrobial Susceptibility Test Systems
ETEST CEFTAROLINE
| Applicant | bioMerieux, Inc., Hazelwood MO, US |
| Decision | Substantially Equivalent, Oct 12, 2012 |
| Received | Apr 2, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121002
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2014 | Biomerieux Etest Ceftaroline (CPT32) WW B30.
Etest (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic Terminated |
JWY | None listed |
| Nov 19, 2014 | Biomerieux Etest Ceftaroline (CPT32) WWB100.
Etest (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic Terminated |
JWY | None listed |
| Nov 19, 2014 | Biomerieux Etest Ceftaroline (CPT32) US B30.
Etest (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic Terminated |
JWY | None listed |
| Nov 19, 2014 | Biomerieux Etest Ceftaroline (CPT32) US B100.
Etest (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic Terminated |
JWY | None listed |
| Nov 19, 2014 | Biomerieux Etest Ceftaroline (CPT32) US B30.
Etest (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic Terminated |
JWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.