Atlas FDA

ETEST FOR GEMIFLOXACIN

FDA 510(k) clearance K042390 · decided 2004-11-19

Clearance details

K-number
K042390
Device name
ETEST FOR GEMIFLOXACIN
Applicant
Ab Biodisk
Decision
Substantially Equivalent
Date received
2004-09-02
Decision date
2004-11-19
Days to decision
78 days
Clearance type
Traditional
Product code
JWY
Device class
2
Regulation number
866.1640
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Solna, SE
Third-party review
No
Expedited review
No

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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
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Recalls involving this device

No recalls on record reference this clearance.