Atlas FDA

MTS Gentamicin 0.016 - 256 µg/mL

FDA 510(k) clearance K190252 · decided 2019-03-22

Clearance details

K-number
K190252
Device name
MTS Gentamicin 0.016 - 256 µg/mL
Applicant
Liofilchem s.r.l.
Decision
Substantially Equivalent
Date received
2019-02-07
Decision date
2019-03-22
Days to decision
43 days
Clearance type
Traditional
Product code
JWY
Device class
2
Regulation number
866.1640
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Roseto Degli Abruzzi, IT
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
ETEST Gepotidacin (GEP) (0.016-256 µg/mL) (K260447)bioMérieux SA2026-04-21
MTS Gepotidacin 0.016-256 µg/mL (K260696)Liofilchem s.r.l.2026-04-17
MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL (K252114)Liofilchem s.r.l.2025-10-02
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
MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) (K251580)Liofilchem s.r.l.2025-08-20
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
ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) (K250856)Biomérieux2025-06-12
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
ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) (K250274)Biomerieux S.A.2025-04-30

Recalls involving this device

No recalls on record reference this clearance.