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) |
|---|---|---|---|
| Oct 9, 2026 | Becton Dickinson & Co. BD Phoenix Panel NMIC-306. Catalog Number: 449292. Open, Classified |
LON | K181665 |
| Oct 9, 2026 | Becton Dickinson & Co. BD Phoenix Panel NMIC-312. Catalog Number: 449082. Open, Classified |
LON | K181665 |
| Sep 18, 2026 | Biomerieux Inc VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811 Open, Classified |
LON | None listed |
| Aug 5, 2026 | Beckman Coulter Inc. REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments:
- B1018-280 MicroScan autoSCAN-4 Instrument
- B1018-283 MicroScan WalkAway-40 plus Instrument
- B1018-2 Open, Classified |
LON | K201405 |
| Aug 5, 2026 | Beckman Coulter Inc. REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments:
- B1018-280 MicroScan autoSCAN-4 Instrument
- B1018-283 MicroScan WalkAway-40 plus Instr Open, Classified |
LON | K201405 |
| Jul 9, 2026 | Biomerieux Inc VITEK 2 AST-N447 TEST KIT
Product reference 424620 Open, Classified |
LON | None listed |
| Oct 23, 2025 | Becton Dickinson & Co. BD Phoenix M50 Instrument, labeled as the following:
1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers: 443624, 44362409. Open, Classified |
LON | K020321 K040099 +1 |
| Sep 29, 2025 | bioMerieux, Inc. VITEK 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n.
VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification Open, Classified |
LON | None listed |
| Dec 3, 2024 | Becton Dickinson & Co. BD Phoenix M50 Automated Microbiology System
Version or Model: 443624
Catalog Number: 443624 Open, Classified |
LON | K020321 K040099 +1 |
| Sep 24, 2024 | Becton Dickinson & Co. BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerob Open, Classified |
LON | K020321 K040099 +1 |
| Sep 24, 2024 | Becton Dickinson & Co. BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results fo Open, Classified |
LON | K020321 K040099 +1 |
| Apr 25, 2024 | Biomerieux Inc VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility):
a) AST-N334, REF 418984;
b) AST-GN95, REF 421982;
c) AST-GN99, REF 423102;
d) AST-N390, REF 423340;
e) Open, Classified |
LON | K161217 |
| Mar 29, 2024 | Becton Dickinson & Co. BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical Open, Classified |
LON | None listed |
| Mar 29, 2024 | Becton Dickinson & Co. BD Phoenix NMIC-306 Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical Open, Classified |
LON | K132674 |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829 Open, Classified |
LON | K152075 |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-GN99 TEST KIT 20 CARDS, CATALOG 423102 Open, Classified |
LON | None listed |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982 Open, Classified |
LON | None listed |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-GP78 TEST KIT 20 CARDS, CATALOG 421051 Open, Classified |
LON | None listed |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915 Open, Classified |
LON | K121100 |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670 Open, Classified |
LON | K032399 |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438 Open, Classified |
LON | K041982 |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437 Open, Classified |
LON | K040845 |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, CATALOG 413436 Open, Classified |
LON | None listed |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS, CATALOG 413404 Open, Classified |
LON | K040485 |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-GN70 TEST KIT 20 CARDS, CATALOG 413401 Open, Classified |
LON | None listed |
| Jan 4, 2023 | Biomerieux Inc VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS, CATALOG 413400 Open, Classified |
LON | K040845 |
| Jan 4, 2023 | Biomerieux Inc ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016 Open, Classified |
LON | None listed |
| Nov 14, 2022 | Becton Dickinson & Co. BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerobic and facultative anaerobic gram-positive bacteria of human origin with selecte Open, Classified |
LON | K070809 |
| Mar 29, 2022 | bioMerieux, Inc. VITEK 2 Systems and VITEK 2 with MYLA. Open, Classified |
LON | None listed |
| Jan 28, 2021 | Biomerieux Inc VITEK 2 Compact (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). V Terminated |
LON | K050002 |
| Jan 28, 2021 | Biomerieux Inc VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 i Terminated |
LON | K050002 |
| Dec 8, 2020 | Becton Dickinson & Co. BD Phoenix PMIC-110: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positi Terminated |
LON | None listed |
| Dec 8, 2020 | Becton Dickinson & Co. BD Phoenix" PMIC-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-posit Terminated |
LON | None listed |
| Dec 8, 2020 | Becton Dickinson & Co. BD Phoenix PMIC/ID-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-pos Terminated |
LON | None listed |
| Dec 8, 2020 | Becton Dickinson & Co. BD Phoenix PMIC-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positi Terminated |
LON | None listed |
| Dec 8, 2020 | Becton Dickinson & Co. BD Phoenix PMIC/ID-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-pos Terminated |
LON | None listed |
| Dec 8, 2020 | Becton Dickinson & Co. BD Phoenix PMIC-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positi Terminated |
LON | None listed |
| Dec 8, 2020 | Becton Dickinson & Co. BD Phoenix PMIC/ID-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-pos Terminated |
LON | None listed |
| Dec 8, 2020 | Becton Dickinson & Co. BD Phoenix PMIC/ID-105: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-pos Terminated |
LON | None listed |
| Mar 15, 2019 | bioMerieux, Inc. Biomerieux Vitek 2 Test kit
VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria Terminated |
LON | None listed |
| Jan 11, 2019 | Organon Teknika Inc Vitek 2 reagent cards:
a) GN ID, REF 21341,
b) GP ID, REF 21342,
c) ANC ID, REF 21347,
d) AST-GNOR, REF 22000,
e) AST-GP67, REF 22226,
f) AST-P612, REF 22359,
g) AST-XN01, REF 410025,
h) AST-N222, Terminated |
LON | None listed |
| Jan 4, 2019 | Remel Inc. SWIN 2017 database, Model YSW4000 Terminated |
LON | None listed |
| Dec 20, 2018 | Becton Dickinson & Co. Phoenix AP AST Indicator Bag, Catalog Number 246006 Terminated |
LON | K050745 |
| Dec 20, 2018 | Becton Dickinson & Co. Phoenix AST Indicator, Catalog Number 246004 Terminated |
LON | K050745 |
| Dec 20, 2018 | Becton Dickinson & Co. Phoenix AST-s Indicator, Catalog Number 246009 Terminated |
LON | K050745 |
| Dec 13, 2018 | bioMerieux, Inc. VITEK 2 AST-N351 Test Kit Terminated |
LON | None listed |
| Nov 13, 2018 | bioMerieux, Inc. VITEK 2 Systems Software Version 9.01 Update Kit. Terminated |
LON | K050002 |
| Oct 22, 2018 | bioMerieux, Inc. VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products:
Catalog # 410028, VITEK 2 AST-ST01
Catalog # 420915, VITEK 2 AST-ST02
Catalog # 421040, VITEK 2 A Terminated |
LON | None listed |
| Aug 30, 2018 | bioMerieux, Inc. bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS General Susceptibility Card
Cefotoxin and AST for Oxacillin
bioMerieux VITEK 2 AST-P631
Terminated |
LON | K053097 |
| Mar 23, 2018 | BioMerieux SA The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobi Terminated |
LON | None listed |
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