Company · US
Thermo Fisher Scientific
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2025. Name variants (Inc, Corp, punctuation) are merged.
65510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | 47 |
| NGZ | Susceptibility Test Plate, Antifungal | 5 |
| IDP | Microtome, Cryostat | 2 |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 2 |
| LRG | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems | 2 |
| CGZ | Electrode, Ion-Specific, Chloride | 1 |
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 1 |
| DIF | Drug Mixture Control Materials | 1 |
| DJR | Enzyme Immunoassay, Methadone | 1 |
| DLJ | Calibrators, Drug Specific | 1 |
| DOP | Mass Spectrometer, Clinical Use | 1 |
| IEO | Processor, Tissue, Automated | 1 |
| JFJ | Catalytic Methods, Amylase | 1 |
| JIF | Enzymatic Method, Ammonia | 1 |
| KLR | Enzyme Immunoassay, Lidocaine | 1 |
| OAV | Mycophenolic Acid Test System | 1 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 25, 2025 | K252062 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL Thermo Fisher Scientific | JWY |
| Sep 5, 2025 | K250575 | The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0. Thermo Fisher Scientific | JWY |
| Aug 28, 2025 | K252014 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL Thermo Fisher Scientific | JWY |
| Jun 30, 2025 | K250990 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 u Thermo Fisher Scientific | JWY |
| Jun 20, 2025 | K242843 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System w Thermo Fisher Scientific | JWY |
| May 22, 2025 | K242659 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/m Thermo Fisher Scientific | JWY |
| Apr 15, 2025 | K242658 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug Thermo Fisher Scientific | JWY |
| Feb 27, 2025 | K243738 | The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL Thermo Fisher Scientific | NGZ |
| Feb 10, 2025 | K243201 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System w Thermo Fisher Scientific | JWY |
| Feb 10, 2025 | K242905 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System w Thermo Fisher Scientific | JWY |
| Dec 19, 2024 | K243169 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug Thermo Fisher Scientific | JWY |
| Dec 5, 2024 | K242653 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL Thermo Fisher Scientific | JWY |
| Nov 26, 2024 | K242657 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL Thermo Fisher Scientific | JWY |
| Oct 9, 2024 | K242021 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System Thermo Fisher Scientific | JWY |
| Oct 1, 2024 | K241967 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System Thermo Fisher Scientific | JWY |
| May 16, 2024 | K240445 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System Thermo Fisher Scientific | JWY |
| Oct 31, 2023 | K232310 | Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Cefto Thermo Fisher Scientific | JWY |
| Aug 31, 2023 | K231433 | The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL Thermo Fisher Scientific | NGZ |
| Aug 30, 2023 | K231988 | Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalba Thermo Fisher Scientific | JWY |
| Aug 25, 2023 | K231994 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/ Thermo Fisher Scientific | JWY |
| Jun 30, 2023 | K230935 | Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imip Thermo Fisher Scientific | JWY |
| Mar 21, 2023 | K223844 | Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delaf Thermo Fisher Scientific | JWY |
| Mar 10, 2023 | K221198 | Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL Thermo Fisher Scientific | NGZ |
| Jan 20, 2023 | K221899 | The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml Thermo Fisher Scientific | NGZ |
| Dec 20, 2021 | K203741 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml Thermo Fisher Scientific | JWY |
| Dec 15, 2021 | K211539 | Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL Thermo Fisher Scientific | NGZ |
| Jul 23, 2021 | K202612 | Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtes Thermo Fisher Scientific | JWY |
| Mar 12, 2020 | K193538 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml Thermo Fisher Scientific | JWY |
| Jan 8, 2020 | K193024 | Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefa Thermo Fisher Scientific | JWY |
| Nov 6, 2019 | K192729 | Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml Thermo Fisher Scientific | JWY |
| Nov 6, 2019 | K191918 | Thermo Scientific Sensititre ARIS HiQ System Thermo Fisher Scientific | LRG |
| Nov 6, 2019 | K191914 | Thermo Scientific Sensititre ARIS HiQ System Thermo Fisher Scientific | LRG |
| Oct 16, 2019 | K192250 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-2 Thermo Fisher Scientific | JWY |
| Feb 15, 2019 | K183324 | Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omada Thermo Fisher Scientific | JWY |
| Jan 4, 2019 | K183033 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml Thermo Fisher Scientific | JWY |
| Nov 30, 2018 | K182797 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL Thermo Fisher Scientific | JWY |
| Aug 8, 2018 | K181946 | Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL Thermo Fisher Scientific | JWY |
| Dec 1, 2017 | K173209 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/ Thermo Fisher Scientific | JWY |
| Oct 13, 2017 | K172454 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL Thermo Fisher Scientific | JWY |
| Aug 30, 2017 | K172274 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with D Thermo Fisher Scientific | JWY |
| Aug 1, 2017 | K171870 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 8 Thermo Fisher Scientific | JWY |
| Dec 21, 2015 | K152774 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0 Thermo Fisher Scientific | JWY |
| Aug 28, 2015 | K150556 | Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL) Thermo Fisher Scientific | JWY |
| Jul 27, 2015 | K150236 | Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL) Thermo Fisher Scientific | JWY |
| Apr 1, 2015 | K143288 | Sensititre Susceptibility plates Thermo Fisher Scientific | JWY |
| Mar 5, 2015 | K143526 | The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml) Thermo Fisher Scientific | JWY |
| Mar 2, 2015 | K142338 | Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml) Thermo Fisher Scientific | JWY |
| Feb 19, 2015 | K143381 | Sensititre Susceptibility Plates Thermo Fisher Scientific | JWY |
| Dec 23, 2014 | K142151 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES Thermo Fisher Scientific | JWY |
| Oct 21, 2014 | K141651 | SENSITITRE SUSCEPTIBILITY PLATES Thermo Fisher Scientific | JWY |
Newest 50 of 65.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 1, 2021 | Thermo Fisher Scientific Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910 Terminated |
DOP | None listed |
| Mar 21, 2011 | Thermo Fisher Scientific Thermo Scientific HM 560 Cold Disinfection Cryostat, Microm International GmbH, Waldorf, Germany
Tissue processing equipment used to prepare human tissue specimens for diagnostic histological examina Terminated |
IDP | None listed |
| Mar 21, 2011 | Thermo Fisher Scientific Thermo Scientific HM 550 Cold Disinfection Cryostat, Microm International GmbH, Waldorf, Germany
Tissue processing equipment used to prepare human tissue specimens for diagnostic histological examin Terminated |
IDP | None listed |
| Apr 12, 2010 | Thermo Fisher Scientific ThermoFisher Scientific Microm STP 420D automated tissue processor. Terminated |
IEO | None listed |
| Oct 4, 2007 | Thermo Fisher Scientific Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic. Terminated |
JIF | K974620 |