Panels › Microbiology › Product code LON · Class 2
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Regulation 866.1645
4510(k)s in 12 months (291 all time)
6recalls in 12 months (240 all time)
161recalls that name a 510(k)
Top companies in LON
| Company | 510(k)s | Recalls |
|---|---|---|
| BIOMERIEUX | 116 | 192 |
| Becton Dickinson & Company | 107 | 29 |
| Dade Behring, Inc. | 37 | 1 |
| Becton, Dickinson and Co. | 15 | 0 |
| Siemens Healthcare Diagnostics | 1 | 13 |
| Bd Diagnostic Systems | 3 | 0 |
| Beckman Coulter, Inc. | 1 | 2 |
| Biomérieux, Inc. | 2 | 0 |
| Copan Wasp Srl | 2 | 0 |
| Dade Microscan, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K020246 K020249 |
| 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 | K020246 K020249 |
| 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 | K020246 K020249 |
| 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 | K020246 K020249 |
| 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 | K020246 K020249 |
| 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 | K020246 K020249 |
| 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 | K020246 K020249 |
| 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 | K020246 K020249 |
| 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 | K020246 K020249 |
| 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 | K020246 K020249 |
| 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 | K020246 K020249 |
| Dec 19, 2012 | Becton Dickinson & Co. BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA.
The BD Phoenix" Automated Microbiology system is intended for the rap Terminated |
LON | K070809 |
| May 24, 2012 | Becton Dickinson & Co. Becton Dickinson Phoenix Update Disks (PUD), catalog # 441107/ 448047, component of BD automated microbiology system, and used with BD Gram Positive MIC or MIC/ID panels.
Product Usage:
The Phoenix Terminated |
LON | K030677 |
| May 24, 2012 | Becton Dickinson & Co. Becton Dickinson Phoenix System Software, catalog # 448035/448046, component of BD automated microbiology system, and used with BD Gram Positive MIC or MIC/ID panels.
Product Usage:
Automated Microb Terminated |
LON | K030677 |
| Apr 27, 2011 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N184, REF 411 154, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, Marcy-l'E Terminated |
LON | K080107 |
| Apr 27, 2011 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N183, REF 411 021, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, Marcy-l'E Terminated |
LON | K080107 |
| Mar 30, 2011 | Becton Dickinson & Co. BD Phoenix" Panel NMIC/ID-123, Catalog # 448723, packaged 25 panels/carton, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA (800) 638-8663***
The BD Phoenix Terminated |
LON | K033458 |
| Nov 15, 2010 | Becton Dickinson & Co. BD Phoenix" ID/AST Panels, Item # PMIC/ID-107, Catalog number 448607, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA (800) 638-8663*** Terminated |
LON | K021954 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N107, REF 22 265, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Mar Terminated |
LON | None listed |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-GN44, REF 410 805, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-GN43, REF 410 759, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-GN40, REF 410 756, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma Terminated |
LON | None listed |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N182, REF 410 804, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N181, REF 410 803, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N180, REF 410 771, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N179, REF 410 640, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N178, REF 410 393, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N177, REF 410 392, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N176, REF 410 402, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N175, REF 410 403, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N174, REF 410 404, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N172, REF 410 298, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N171, REF 410 249, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N170, REF 410 222, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N168, REF 410 139, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N167, REF 410 138, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N166, REF 410 136, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N165, REF 410 102, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N164, REF 410 101, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N163, REF 410 084, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N162, REF 410 023, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N161, REF 410 026, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Ma Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N160, REF 22 357, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Mar Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N159, REF 22 356, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Mar Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N158, REF 22 355, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Mar Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N157, REF 22 354, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Mar Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N156, REF 22 353, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Mar Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N155, REF 22 352, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Mar Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N153, REF 22 348, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Mar Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N152, REF 22 347, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Mar Terminated |
LON | K080107 |
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