510(k) K020246 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25, 1-32 UG/ML)
| Applicant | Dade Behring, Inc., West Sacramento CA, US |
| Decision | Substantially Equivalent, Feb 6, 2002 |
| Received | Jan 24, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020246
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2013 | Siemens Healthcare Diagnostics, Inc. Microscan Synergies Plus Negative Urine Combo 1
Product Usage:
MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobia Terminated |
LON | None listed |
| Sep 11, 2013 | Siemens Healthcare Diagnostics, Inc. Microscan Synergies Plus Negative Combo 2
Product Usage:
MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial age Terminated |
LON | None listed |
| Sep 11, 2013 | Siemens Healthcare Diagnostics, Inc. Microscan Synergies Plus Negative Breakpoint Combo 7
Product Usage:
MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimic Terminated |
LON | None listed |
| Sep 11, 2013 | Siemens Healthcare Diagnostics, Inc. Microscan Synergies Plus Negative Urine Combo 2
Product Usage:
MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobia Terminated |
LON | None listed |
| Sep 11, 2013 | Siemens Healthcare Diagnostics, Inc. Microscan Synergies Plus Negative Urine Combo 5
Product Usage:
MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobi Terminated |
LON | None listed |
| Sep 11, 2013 | Siemens Healthcare Diagnostics, Inc. Microscan plus Negative Combo 3
Sold outside of US only.
Product Usage:
MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative an Terminated |
LON | None listed |
| Sep 11, 2013 | Siemens Healthcare Diagnostics, Inc. Microscan plus Negative Urine Combo 4
Sold outside of US only.
Product Usage:
MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitat Terminated |
LON | None listed |
| Sep 11, 2013 | Siemens Healthcare Diagnostics, Inc. Microscan plus Negative Breakpoint Combo 4
Sold outside of US only.
Product Usage:
MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qua Terminated |
LON | None listed |
| Sep 11, 2013 | Siemens Healthcare Diagnostics, Inc. MicroscanrapID/S panels NC3.11
Sold in Japan only.
Product Usage:
MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimic Terminated |
LON | None listed |
| Sep 11, 2013 | Siemens Healthcare Diagnostics, Inc. Microscan rapID/S panels NC3.12
Sold in Japan only.
Product Usage:
MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimi Terminated |
LON | None listed |
| Sep 11, 2013 | Siemens Healthcare Diagnostics, Inc. Microscan rapID/S panels NC3.33
Sold in Japan only.
Product Usage:
MicroScan Synergies plus Panels & MicroScan Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimi Terminated |
LON | None listed |
| Feb 4, 2009 | Siemens Microscan MicroScan Synergies Plus Dried Overnight Gram Negative MIC/Combo Panels, 20 panels per box. Medical device designed for use in determining quantitative and/or qualitative antimicrobial agent suscepti Terminated |
LON | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.