510(k) K862140 ยท JWY Manual Antimicrobial Susceptibility Test Systems
MICRODILUTION PANELS
| Applicant | American Micro Scan, West Sacramento CA, US |
| Decision | Substantially Equivalent, Jul 16, 1986 |
| Received | Jun 4, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862140
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 26, 2015 | Beckman Coulter, Inc. MicroScan -Neg Breakpoint Combo Panel Type 34;
Catalog number B1017-404; Panel
MicroScan Neg Breakpoint 34 Neg panels are designed for use in determining quantitative and /or qualitative antimicrobial Terminated |
JWY | None listed |
| May 8, 2012 | Siemens Healthcare Diagnostics, Inc. MicroScan Dried Overnight Gram Negative Panels;
Panel type: Neg Urine Combo 55; Catalog Number B1017-409.
Siemens Healthcare Diagnostics,
West Sacramento, CA. Terminated |
JWY | None listed |
| May 8, 2012 | Siemens Healthcare Diagnostics, Inc. MicroScan Dried Overnight Gram Negative Panels;
Panel type: Neg Breakpoint Combo Type 34, catalog number: B1017-404.
Siemens Healthcare Diagnostics,
West Sacramento, CA. Terminated |
JWY | None listed |
| May 8, 2012 | Siemens Healthcare Diagnostics, Inc. MicroScan Dried Overnight Gram Negative Panels;
Panel type: Neg Breakpoint Combo Type 47, catalog number: B1017-417.
Siemens Healthcare Diagnostics,
West Sacramento, CA.
For use in determining qua Terminated |
JWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.