FDA.report

510(k) K252114

Device
MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL
Applicant
Liofilchem s.r.l.
510(k) number
K252114
Product code
JWY
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-02
Date received
2025-07-07
Regulation
866.1640
Classification name
Manual Antimicrobial Susceptibility Test Systems
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Fabio Rocco
Address
Via Scozia, Zona Industriale 64026 Roseto Degli Abruzzi IT

FDA Registration Numbers

Source Documents

510(k) summary PDF

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