Data / Medical devices / United States / bioMerieux, Inc.
bioMerieux, Inc.: FDA-registered device maker in Morrisville, NC, United States, 120 510(k) clearances and 1 PMA approval
bioMerieux, Inc. is registered with the FDA (registration 3031977134) in Morrisville, NC, United States. It lists 6 device types. The FDA files 120 510(k) clearances and 1 PMA approval under its listings, the newest dated June 12, 2024. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3031977134
- Address
- 3015 Carrington Mill Blvd, Morrisville, NC, United States, 27560
- Owner or operator
- BIOMERIEUX SA (8020790)
- Roles
- Complaint file establishment
- First device listed
- December 6, 2007
- Registered through
- 2027
- Brand names listed
- (240),, (<= 0.12 - >= 8 mcg/ml), 3D Combination, AST Cefotaxime, AST Clindamycin, AST Penicillin, AST Streptococcus Vancomycin, AST-GN Imipenem and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | LRG | 2 | Complaint file establishment | accessdata.fda.gov |
| Panels, Test, Susceptibility, Antimicrobial | LTT | 2 | Complaint file establishment | accessdata.fda.gov |
| Susceptibility Test Cards, Antimicrobial | LTW | 2 | Complaint file establishment | accessdata.fda.gov |
| Susceptibility Test Plate, Antifungal | NGZ | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Blood Culturing | MDB | 1 | Complaint file establishment | accessdata.fda.gov |
| System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | LON | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 120.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 12, 2024 | K232967 | VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) | NGZ | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| June 7, 2024 | K232963 | VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) | NGZ | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| March 11, 2024 | K234000 | VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 23, 2023 | K232201 | VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| July 5, 2023 | K230864 | VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| June 26, 2023 | K222378 | VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| March 9, 2023 | K222430 | VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin | LON | Substantially Equivalent | Biomerieux Sa, Inc. | accessdata.fda.gov |
| February 16, 2023 | K223478 | VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 9, 2023 | K222073 | VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 3, 2023 | K223481 | VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| January 27, 2023 | K220803 | VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 13, 2022 | K220805 | VITEK 2 AST-Gram Positive Cefoxitin Screen | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| August 8, 2022 | K212243 | VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| July 12, 2022 | K213899 | VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| June 3, 2022 | K213931 | VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| April 14, 2022 | K214023 | VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 25, 2022 | K213241 | VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 4, 2022 | K212849 | VITEK 2 AST-Gram Positive Linezolid (<=0.5 >=8 µg/mL) | LON | Substantially Equivalent | Biomérieux, Inc. | accessdata.fda.gov |
| October 28, 2021 | K210287 | VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| September 14, 2021 | K202396 | VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| August 30, 2021 | K211630 | VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| July 9, 2021 | K201675 | VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| June 14, 2021 | K211136 | VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| September 28, 2020 | K193299 | VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| April 28, 2020 | K200590 | VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| March 13, 2020 | K193572 | VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 14, 2020 | K193567 | VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 >=16 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 31, 2019 | K192110 | Vitek Densichek | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| August 5, 2019 | K191766 | VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| June 6, 2019 | K190616 | VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| May 15, 2019 | K190405 | BACT/ALERT MP Reagent System | MDB | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| March 12, 2019 | K183524 | VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| March 7, 2019 | K183551 | VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 26, 2019 | K183360 | VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 >=64/8 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 20, 2019 | K183415 | VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 11, 2019 | K183166 | BacT/ALERT FA Plus; BacT/ALERT PF Plus | MDB | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| December 10, 2018 | K181766 | VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| December 19, 2017 | K172944 | VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 >=16 µg/mL | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| December 8, 2017 | K172731 | VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| June 21, 2017 | K162737 | VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| March 28, 2017 | K161816 | BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO | MDB | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| March 13, 2017 | K163563 | VITEK 2 AST-GN Gentamicin (<=1 >=16 µg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 16, 2017 | K161437 | VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 13, 2017 | K161510 | VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 1, 2017 | K163083 | VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| January 24, 2017 | K163006 | VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| January 12, 2017 | K161217 | VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| July 20, 2016 | K161227 | VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| April 15, 2016 | K152075 | VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL) | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| June 20, 2014 | K141149 | VITEK 2 AST GP CEFTAROLINE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| November 15, 2013 | K132507 | VITEK 2 AST ST MEROPENEM | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 10, 2013 | K131779 | VITEK 2 AST-ST TIGECYCLINE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| September 13, 2013 | K132573 | VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| January 25, 2013 | K121455 | BACT/ALERT FN PLUS CULTURE BOTTLE | MDB | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| January 25, 2013 | K121446 | BACT/ALERT PF PLUS CULTURE BOTTLE | MDB | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| January 22, 2013 | K121461 | BACT/ALERT FA PLUS CULTURE BOTTLE | MDB | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| November 20, 2012 | K121546 | VITEK 2 GRAM NEGATIVE DOXYCYCLINE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| November 19, 2012 | K121100 | VITEK 2 AST STREPTOCOCUS VANCOMYCIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 15, 2012 | K122547 | GRAM POSTITVE CLINDAMYCIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| August 28, 2012 | K122359 | VITEK 2 STRPTOCOCCUS CEFTRIAXONE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| August 16, 2012 | K121863 | VITEK 2 AST-ST CEFOTAXIME | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| August 7, 2012 | K113783 | VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| June 29, 2012 | K113200 | VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 28, 2012 | K111893 | VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 17, 2012 | K111976 | VITEK 2 STREPTOCOCCUS ERYTHROMYCIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 10, 2012 | K113305 | VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| November 30, 2011 | K110106 | VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 26, 2011 | K112000 | VITEK 2 STREPTOCOCCUS PENICILLIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 18, 2011 | K111909 | VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 14, 2011 | K103752 | VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 3, 2011 | K112228 | VITEK 2 STREPTOCOCCUS LEVOFLOXACIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| September 27, 2011 | K112129 | VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| September 15, 2011 | K112075 | VITEK 2 STRPTOCOCCUS AMPICILLIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| August 12, 2011 | K111599 | VITEK 2 AST-ST LINEZOLID | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 21, 2010 | K093076 | VITEK 2 GRAM POSITIVE DOXCYCLINE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| November 9, 2009 | K093224 | DENSICHECK PLUS | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| September 11, 2009 | K083536 | DENSICHEK PLUS | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| August 14, 2009 | K091899 | VITEK 2 GRAM NEGATIVE MEROPENEM | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| June 18, 2009 | K091126 | VITEK 2 GRAM POSITIVE DAPTOMYCIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| March 16, 2009 | K082346 | VITEK 2 GRAM NEGATIVE DORIPENEM | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 18, 2009 | K083383 | VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| April 30, 2008 | K080201 | VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 28, 2008 | K080107 | VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| January 23, 2008 | K073406 | VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| December 10, 2007 | K073083 | VITEK 2 GRAM NEGATIVE PIPERACILLIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| November 16, 2007 | K072695 | VITEK 2 GRAM POSITIVE TIGECYCLINE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| October 15, 2007 | K072668 | VITEK 2 GRAM POSITIVE VANCOMYCIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| September 12, 2007 | K072038 | VITEK 2 GRAM NEGATIVE LEVOFLOXACIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| January 19, 2007 | K063597 | VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| January 11, 2007 | K063623 | VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| December 21, 2006 | K063492 | VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| June 20, 2006 | K061347 | VITEK 2 GRAM POSITIVE VRSA SCREEN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| December 14, 2005 | K053097 | VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| December 1, 2005 | K053186 | VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| September 29, 2005 | K052311 | VITEK 2 GRAM NEGATIVE TIGECYCLINE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| August 16, 2005 | K051849 | VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| May 23, 2005 | K050976 | VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| May 12, 2005 | K050816 | VITEK 2 GRAM POSITIVE MEROPENEM | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 28, 2005 | K050075 | VITEK 2 GRAM POSITIVE DAPTOMYCIN | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
| February 18, 2005 | K050076 | VITEK 2 GRAM POSITIVE ERTAPENEM | LON | Substantially Equivalent | bioMerieux, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| March 2, 1978 | N50510 | VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD | LTW | 130 | October 17, 2001 | accessdata.fda.gov |
Compare with other makers
- All makers of System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- All makers of Panels, Test, Susceptibility, Antimicrobial
- All makers of Susceptibility Test Cards, Antimicrobial
- All makers of System, Blood Culturing
- All makers of Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
- All makers of Susceptibility Test Plate, Antifungal
Updated June 12, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.