510(k) clearances

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

Thermo Fisher Scientific · Microbiology

K242905Substantially EquivalentTraditionalJWY
Open FDA's page for this record
Third party flag
N
City
Oakwood Village
Advisory committee description
Microbiology
Address 1
1 Thermofisher Way
Statement or summary
Statement
Product code
JWY
Zip code
44146
Applicant
Thermo Fisher Scientific
Decision date
2025-02-10
Decision code
SESE
Country code
US
Advisory committee
MI
Contact
Joel Mathew
K number
K242905
State
OH
Date received
2024-09-24
Review advisory committee
MI
Postal code
44146
Decision description
Substantially Equivalent
Clearance type
Traditional
Device name

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

Harmonized identifiers (openFDA)
Device name
Manual Antimicrobial Susceptibility Test Systems
Medical specialty description
Microbiology
Regulation number
866.1640
Device class
2
Registration number
2919016, 1530126, 3003750284, 8021914, 1924669, 9615754, 1119779, 3013661582, 3012389632
FEI number
3002806332, 2919016, 1000515493, 3008237827, 3003750284, 1924669, 1119779, 3013661582, 3012389632
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.