510(k) K870074 ยท JWY Manual Antimicrobial Susceptibility Test Systems
GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS
| Applicant | Microscan Div. Baxter Healthcare Corp., West Sacramento CA, US |
| Decision | Substantially Equivalent, Apr 14, 1987 |
| Received | Jan 8, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K870074
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 27, 2015 | Beckman Coulter, Inc. MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels
Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20
Breakpoints
Panel: Neg Combo 50, Catalog B1017-406
Microbiology: F Terminated |
JWY | None listed |
| Apr 27, 2015 | Beckman Coulter, Inc. MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels
Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20
Breakpoints
Panel: Neg/BP Combo 47, Catalog B1017-417
Microbiology Terminated |
JWY | None listed |
| Apr 27, 2015 | Beckman Coulter, Inc. MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels
Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20
Breakpoints
Panel: Neg/Urine Combo 51, Catalog B1017-407
Microbiol Terminated |
JWY | None listed |
| Apr 27, 2015 | Beckman Coulter, Inc. MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels
Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20
Breakpoints
Panel: Neg/Urine Combo 55, Catalog B1017-409
Microbio Terminated |
JWY | None listed |
| Apr 27, 2015 | Beckman Coulter, Inc. MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels
Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20
Breakpoints
Panel: Neg/Urine Combo 61, Catalog B1017-414
Microbio Terminated |
JWY | None listed |
| Apr 27, 2015 | Beckman Coulter, Inc. MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels
Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20
Breakpoints
Panel: Neg MIC 38, Catalog B1017-412
Microbiology: For Terminated |
JWY | None listed |
| Apr 27, 2015 | Beckman Coulter, Inc. MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels
Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20
Breakpoints
Panel: ESL plus, Catalog B1027-101
Microbiology: For u Terminated |
JWY | None listed |
| Apr 27, 2015 | Beckman Coulter, Inc. MicroScan Pos Combo Panel Type 33 (PC33):
Catalog number B1017-211
MicroScan Pos Combo 33 B1017-211 panels are designed for use in determining quantitative and /or qualitative antimicrobial agent s Terminated |
JWY | None listed |
| Feb 4, 2009 | Siemens Microscan MicroScan Synergies Plus Negative Panels, 20 panels per box
Medical device designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification to t Terminated |
JWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.