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Thermo Fisher Scientific

64 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL (K252062)Thermo Fisher Scientific2025-09-25
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL (K250575)Thermo Fisher Scientific2025-09-05
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL (K252014)Thermo Fisher Scientific2025-08-28
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL (K250990)Thermo Fisher Scientific2025-06-30
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. (K242843)Thermo Fisher Scientific2025-06-20
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL (K242659)Thermo Fisher Scientific2025-05-22
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL (K242658)Thermo Fisher Scientific2025-04-15
The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL (K243738)Thermo Fisher Scientific2025-02-27
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL (K243201)Thermo Fisher Scientific2025-02-10
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL (K242905)Thermo Fisher Scientific2025-02-10
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL (K243169)Thermo Fisher Scientific2024-12-19
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL (K242653)Thermo Fisher Scientific2024-12-05
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL (K242657)Thermo Fisher Scientific2024-11-26
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml. (K242021)Thermo Fisher Scientific2024-10-09
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml. (K241967)Thermo Fisher Scientific2024-10-01
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml. (K240445)Thermo Fisher Scientific2024-05-16
Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml (K232310)Thermo Fisher Scientific2023-10-31
The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL (K231433)Thermo Fisher Scientific2023-08-31
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml (K231988)Thermo Fisher Scientific2023-08-30
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL (K231994)Thermo Fisher Scientific2023-08-25
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) (K230935)Thermo Fisher Scientific2023-06-30
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) (K223844)Thermo Fisher Scientific2023-03-21
Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL (K221198)Thermo Fisher Scientific2023-03-10
The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml (K221899)Thermo Fisher Scientific2023-01-20
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml (K203741)Thermo Fisher Scientific2021-12-20
Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL (K211539)Thermo Fisher Scientific2021-12-15
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) (K202612)Thermo Fisher Scientific2021-07-23
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml (K193538)Thermo Fisher Scientific2020-03-12
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL (K193024)Thermo Fisher Scientific2020-01-08
Thermo Scientific Sensititre ARIS HiQ System (K191918)Thermo Fisher Scientific2019-11-06
Thermo Scientific Sensititre ARIS HiQ System (K191914)Thermo Fisher Scientific2019-11-06
Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml (K192729)Thermo Fisher Scientific2019-11-06
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL (K192250)Thermo Fisher Scientific2019-10-16
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 (K183324)Thermo Fisher Scientific2019-02-15
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml (K183033)Thermo Fisher Scientific2019-01-04
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL (K182797)Thermo Fisher Scientific2018-11-30
Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL (K181946)Thermo Fisher Scientific2018-08-08
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mL (K173209)Thermo Fisher Scientific2017-12-01
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL (K172454)Thermo Fisher Scientific2017-10-13
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8µg/mL (K172274)Thermo Fisher Scientific2017-08-30
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 – 8 ug/mL (K171870)Thermo Fisher Scientific2017-08-01
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 (K152774)Thermo Fisher Scientific2015-12-21
Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL) (K150556)Thermo Fisher Scientific2015-08-28
Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL) (K150236)Thermo Fisher Scientific2015-07-27
Sensititre Susceptibility plates (K143288)Thermo Fisher Scientific2015-04-01
The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml) (K143526)Thermo Fisher Scientific2015-03-05
Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml) (K142338)Thermo Fisher Scientific2015-03-02
Sensititre Susceptibility Plates (K143381)Thermo Fisher Scientific2015-02-19
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES (K142151)Thermo Fisher Scientific2014-12-23
SENSITITRE SUSCEPTIBILITY PLATES (K141651)Thermo Fisher Scientific2014-10-21
SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) SUSCEPTIBILITY PLATES (K133847)Thermo Fisher Scientific2014-08-01
SENSITITRE SUSCEPTIBILITY PLATES (K141000)Thermo Fisher Scientific2014-07-16
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP) SUSCEPTIBILITY PLATES (K140985)Thermo Fisher Scientific2014-06-10
SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM (K133773)Thermo Fisher Scientific2014-02-27
IMMUNOCAP ALLERGEN K82 (K121463)Thermo Fisher Scientific2013-01-29
REMEL SPECTRA VRE (K092819)Thermo Fisher Scientific2010-07-15
XPECT FLU A & B (K092423)Thermo Fisher Scientific2009-08-26
QMS LIDOCAINE CALIBRATORS, MODEL 0374678 (K091617)Thermo Fisher Scientific2009-07-17
DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS (K081378)Thermo Fisher Scientific2009-01-14
CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS (K081083)Thermo Fisher Scientific2008-12-19
MAS TOX CONTROL (K080085)Thermo Fisher Scientific2008-04-30
SPECTRA MRSA (K073027)Thermo Fisher Scientific2008-02-28
ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZER (K070531)Thermo Fisher Scientific2007-09-04
AMYLASE EPS REAGENT (K070064)Thermo Fisher Scientific2007-05-22

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Every clearance here is in the API, with alerts when new ones post.