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

Company510(k)sRecalls
BIOMERIEUX116192
Becton Dickinson & Company10729
Dade Behring, Inc.371
Becton, Dickinson and Co.150
Siemens Healthcare Diagnostics113
Bd Diagnostic Systems30
Beckman Coulter, Inc.12
Biomérieux, Inc.20
Copan Wasp Srl20
Dade Microscan, Inc.20
Decided510(k)Device and applicantCode
Oct 1, 2026K260283VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)
bioMerieux, Inc.
LON
Sep 28, 2026K260619VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL)
Biomérieux, Inc.
LON
Apr 15, 2026K260282VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance
bioMerieux, Inc.
LON
Mar 26, 2026K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)
BIOMERIEUX
LON
Aug 21, 2025K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)
bioMerieux, Inc.
LON
Aug 8, 2025K251713BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)
Becton, Dickinson and Company
LON
May 19, 2025K250447BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)
Becton, Dickinson and Company
LON
Mar 14, 2025K234012VITEK COMPACT PRO
bioMerieux, Inc.
LON
Mar 6, 2025K250344BD Phoenix™ Automated Microbiology System
Becton, Dickinson and Company
LON
Mar 15, 2024K233986BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)
Becton, Dickinson and Company
LON
Mar 11, 2024K234000VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)
bioMerieux, Inc.
LON
Dec 27, 2023K232756Colibrí
Copan Wasp Srl, IT
LON
Oct 23, 2023K232201VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK
bioMerieux, Inc.
LON
Jul 5, 2023K230864VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-G
bioMerieux, Inc.
LON
Jun 26, 2023K222378VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL)
bioMerieux, Inc.
LON
Apr 19, 2023K211748Selux AST System; Model AST Gen 1.0
Selux Diagnostics, Inc.
LON
Mar 9, 2023K222430VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN
Biomerieux Sa, Inc.
LON
Feb 16, 2023K223478VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-
bioMerieux, Inc.
LON
Feb 9, 2023K222073VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)
bioMerieux, Inc.
LON
Feb 3, 2023K223481VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)
bioMerieux, Inc.
LON
Jan 27, 2023K220803VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-
bioMerieux, Inc.
LON
Jan 18, 2023K211759Selux AST System; Model AST Gen 1.0
Selux Diagnostics, Inc.
LON
Oct 13, 2022K220805VITEK 2 AST-Gram Positive Cefoxitin Screen
bioMerieux, Inc.
LON
Oct 5, 2022K220546Colibrí System
Copan Wasp Srl, IT
LON
Aug 8, 2022K212243VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)
bioMerieux, Inc.
LON
Jul 12, 2022K213899VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-
bioMerieux, Inc.
LON
Jun 3, 2022K213931VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)
bioMerieux, Inc.
LON
Apr 14, 2022K214023VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)
bioMerieux, Inc.
LON
Feb 25, 2022K213241VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconaz
bioMerieux, Inc.
LON
Feb 4, 2022K212849VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)
Biomérieux, Inc.
LON
Oct 28, 2021K210287VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)
bioMerieux, Inc.
LON
Sep 14, 2021K202396VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)
bioMerieux, Inc.
LON
Aug 30, 2021K211630VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)
bioMerieux, Inc.
LON
Jul 9, 2021K201675VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)
bioMerieux, Inc.
LON
Jun 14, 2021K211136VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)
bioMerieux, Inc.
LON
Sep 28, 2020K193299VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)
bioMerieux, Inc.
LON
Aug 30, 2020K201405LabPro Data Management System
Beckman Coulter, Inc.
LON
Apr 28, 2020K200590VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)
bioMerieux, Inc.
LON
Mar 13, 2020K193572VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)
bioMerieux, Inc.
LON
Feb 14, 2020K193567VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL)
bioMerieux, Inc.
LON
Oct 31, 2019K192110Vitek Densichek
bioMerieux, Inc.
LON
Aug 5, 2019K191766VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)
bioMerieux, Inc.
LON
Jul 1, 2019K190905BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL)
Becton, Dickinson and Company
LON
Jun 6, 2019K190616VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)
bioMerieux, Inc.
LON
Mar 12, 2019K183524VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)
bioMerieux, Inc.
LON
Mar 7, 2019K183551VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL)
bioMerieux, Inc.
LON
Feb 26, 2019K183360VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 – >=64/8 µg/mL)
bioMerieux, Inc.
LON
Feb 20, 2019K183415VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)
bioMerieux, Inc.
LON
Dec 10, 2018K181766VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance
bioMerieux, Inc.
LON
Sep 21, 2018K181665BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN
Becton, Dickinson and Company
LON

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