ClearanceBrief
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)
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Top companies in LON

DateFirm and productCodeLinked 510(k)
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Nov 11, 2010Biomerieux 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
LONK080107
Aug 27, 2010Biomerieux 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
LONNone listed
Feb 4, 2009Siemens 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
LONK020246
Apr 6, 2005Dade Behring
MicroScan Rapid Pos Inoculum Broth, Catalog #: B1015-14; Manufactured and distributed by: Dade Behring Inc. 2040 Enterprise Blvd. West Sacramento, CA 95691
Terminated
LONNone listed
Nov 30, 2004Becton Dickinson & Co.
BD Phoenix ID/AST panels, catalog numbers 448007, 448008, 448400, 448452, 448459, 448600, and 448708, packaged in cartons of 25 panels.
Terminated
LONNone listed
Jul 20, 2004bioMerieux 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
LONNone listed
Jul 20, 2004bioMerieux 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
LONNone listed
Jul 20, 2004bioMerieux 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
LONNone listed
Jul 20, 2004bioMerieux 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
LONNone listed

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