# Thermo Fisher Scientific

- Location (FDA's records): Oakwood Village, OH
- FDA decisions: 65 (2007–2025): 65 510(k) clearances
- Names in FDA's records: Thermo Fisher Scientific (64); Thermo Fisher Scientific, Inc. (1)
- Product codes: JWY (47), NGZ (5), LRG (2), JSO (2), DJR (1), OAV (1), KLR (1), DIF (1), JFJ (1), DLJ (1), DHB (1), CGZ (1)
- 510(k) review time since 2016: median 88 days, against 90 for FDA's reviews in the same codes and years (15 of 37 faster)
- Predicates its devices cite: 7 (0 its own); citations of its devices by later devices: 4 (0 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boehringer Mannheim Corp.: 2 (https://510kreport.com/company/boehringer-mannheim)
- Roche Diagnostics Corp.: 2 (https://510kreport.com/company/roche-diagnostics)
- Microgenics Corp.: 1 (https://510kreport.com/company/microgenics)
- Pharmacia, Inc.: 1 (https://510kreport.com/company/pharmacia)
- Remel Co.: 1 (https://510kreport.com/company/remel)

## Firms that cite its devices most
- Bio-Rad: 2 (https://510kreport.com/company/bio-rad)
- Biosite Incorporated: 1 (https://510kreport.com/company/biosite)
- Beckman Coulter, Inc.: 1 (https://510kreport.com/company/beckman-coulter)

## Its most-cited devices
- K092819: Remel Spectra Vre (2010), cited by 2
- K081378: Dri Methadone Metabolite (100/300) Assay, Calibrators and Controls (2009), cited by 1
- K070064: Amylase Eps Reagent (2007), cited by 1

## Recent decisions
- K252062: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL (Sep 25, 2025)
- K250575: 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 (Sep 5, 2025)
- K252014: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL (Aug 28, 2025)
- K250990: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL (Jun 30, 2025)
- K242843: 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. (Jun 20, 2025)
- K242659: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL (May 22, 2025)
- K242658: The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL (Apr 15, 2025)
- K243738: The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL (Feb 27, 2025)

Source page: https://510kreport.com/company/thermo-fisher-scientific