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) |
|---|---|---|---|
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N093, REF 22 246, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N093, REF 22 243, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N091, REF 22 241, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N090, REF 22 240, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N089, REF 22 237, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N088, REF 22 236, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N087, REF 22 235, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N086, REF 22 234, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N085, REF 22 225, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N084, REF 22 224, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N082, REF 22 217, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N081, REF 22 215, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-N080, REF 22 214, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-GN42, REF 410 758, 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-GN41, REF 410 757, 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-GN39, REF 22 337, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-GN37, REF 22 312, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-GN36, REF 22 300, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-GN35, REF 22 286, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-GN34, REF 22 271, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-GN33, REF 22 270, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-GN32, REF 22 269, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-GN31, REF 22 268, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-GN30, REF 22 267, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-GN29, REF 22 266, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-GN28, REF 22 254, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-GN27, REF 22 245, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-GN26, REF 22 244, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-GN25, REF 22 230, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-GN24, REF 22 229, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-GN23, REF 22 228, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Nov 11, 2010 | Biomerieux Inc VITEK 2 Gram Negative Susceptibility Card, AST-GN22, REF 22 227, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marc Terminated |
LON | K080107 |
| Aug 27, 2010 | Biomerieux Inc VITEK TWO AST-N085 REF 22 225 For In Vitro Diagnostic Use - each test card is packaged into a foil pouch with 20 pouches per box. The firm name on the label is bioMerieux, Inc., Durham, NC and bioMer 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 | K020246 |
| Apr 6, 2005 | Dade Behring MicroScan Rapid Pos Inoculum Broth, Catalog #: B1015-14; Manufactured and distributed by: Dade Behring Inc. 2040 Enterprise Blvd. West Sacramento, CA 95691 Terminated |
LON | None listed |
| Nov 30, 2004 | Becton Dickinson & Co. BD Phoenix ID/AST panels, catalog numbers 448007, 448008, 448400, 448452, 448459, 448600, and 448708, packaged in cartons of 25 panels. Terminated |
LON | None listed |
| Jul 20, 2004 | bioMerieux Inc VITEK GPS-107 Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC. Terminated |
LON | None listed |
| Jul 20, 2004 | bioMerieux Inc VITEK GPS-107Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC. Terminated |
LON | None listed |
| Jul 20, 2004 | bioMerieux Inc VITEK GPS-107Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC. Terminated |
LON | None listed |
| Jul 20, 2004 | bioMerieux Inc VITEK GPS-106 Gram Positive Susceptibility Card, Catalog #V4335, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC and bioMerieux sa Terminated |
LON | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.