510(k) K020160 ยท LTT Panels, Test, Susceptibility, Antimicrobial
DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN
| Applicant | Dade Behring, Inc., West Sacramento CA, US |
| Decision | Substantially Equivalent, Mar 14, 2002 |
| Received | Jan 17, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020160
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2018 | Beckman Coulter Inc. MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultati Terminated |
LTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.