FDA 510(k) Applications Submitted by THERMO FISHER SCIENTIFIC

FDA 510(k) Number Submission Date Device Name Applicant
K070531 02/23/2007 ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER Thermo Fisher Scientific
K150236 02/02/2015 Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL) THERMO FISHER SCIENTIFIC
K150556 03/04/2015 Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL) THERMO FISHER SCIENTIFIC
K230935 04/03/2023 Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae) Thermo Fisher Scientific
K140985 04/16/2014 SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP) SUSCEPTIBILITY PLATES Thermo Fisher Scientific
K141000 04/18/2014 SENSITITRE SUSCEPTIBILITY PLATES Thermo Fisher Scientific
K221198 04/26/2022 Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL Thermo Fisher Scientific
K231433 05/17/2023 The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL Thermo Fisher Scientific
K211539 05/18/2021 Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL Thermo Fisher Scientific
K141651 06/20/2014 SENSITITRE SUSCEPTIBILITY PLATES Thermo Fisher Scientific
K171870 06/22/2017 The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 û 8 ug/mL Thermo Fisher Scientific
K221899 06/30/2022 The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml Thermo Fisher Scientific
K231994 07/05/2023 Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL Thermo Fisher Scientific
K191914 07/17/2019 Thermo Scientific Sensititre ARIS HiQ System Thermo Fisher Scientific
K191918 07/18/2019 Thermo Scientific Sensititre ARIS HiQ System Thermo Fisher Scientific
K181946 07/20/2018 Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL Thermo Fisher Scientific
K172274 07/28/2017 The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8╡g/mL Thermo Fisher Scientific
K142151 08/06/2014 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES Thermo Fisher Scientific
K172454 08/14/2017 Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL Thermo Fisher Scientific
K192250 08/19/2019 Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL Thermo Fisher Scientific
K142338 08/21/2014 Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml) THERMO FISHER SCIENTIFIC
K202612 09/09/2020 Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL) Thermo Fisher Scientific
K152774 09/25/2015 The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL THERMO FISHER SCIENTIFIC
K192729 09/27/2019 Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml Thermo Fisher Scientific
K182797 10/01/2018 Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 ╡g/mL Thermo Fisher Scientific
K173209 10/02/2017 Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mL Thermo Fisher Scientific
K193024 10/30/2019 Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL Thermo Fisher Scientific
K183033 11/01/2018 Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml Thermo Fisher Scientific
K143288 11/17/2014 Sensititre Susceptibility plates THERMO FISHER SCIENTIFIC
K143381 11/25/2014 Sensititre Susceptibility Plates Thermo Fisher Scientific
K183324 11/30/2018 Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL Thermo Fisher Scientific
K133773 12/12/2013 SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM Thermo Fisher Scientific
K143526 12/12/2014 The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml) Thermo Fisher Scientific
K133847 12/18/2013 SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) SUSCEPTIBILITY PLATES Thermo Fisher Scientific
K193538 12/20/2019 Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ╡g/ml Thermo Fisher Scientific
K203741 12/22/2020 Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml Thermo Fisher Scientific
K223844 12/22/2022 Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae) Thermo Fisher Scientific
K080085 01/11/2008 MAS TOX CONTROL Thermo Fisher Scientific
K081083 04/16/2008 CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS Thermo Fisher Scientific
K081378 05/16/2008 DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS Thermo Fisher Scientific
K091617 06/03/2009 QMS LIDOCAINE CALIBRATORS, MODEL 0374678 Thermo Fisher Scientific
K231988 07/05/2023 Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2╡g/ml Thermo Fisher Scientific
K121463 05/17/2012 IMMUNOCAP ALLERGEN K82 Thermo Fisher Scientific
K092423 08/07/2009 XPECT FLU A & B Thermo Fisher Scientific
K092819 09/14/2009 REMEL SPECTRA VRE Thermo Fisher Scientific
K073027 10/26/2007 SPECTRA MRSA Thermo Fisher Scientific
K070064 01/05/2007 AMYLASE EPS REAGENT Thermo Fisher Scientific


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