Cleared Traditional

ComASP Cefiderocol 0.008-128

K230479 · Liofilchem S. R. L. · Microbiology
May 2023
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K230479 is an FDA 510(k) clearance for the ComASP Cefiderocol 0.008-128, a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by Liofilchem S. R. L. (Roseto Degli Abruzzi, IT). The FDA issued a Cleared decision on May 18, 2023, 85 days after receiving the submission on February 22, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K230479 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 2023
Decision Date May 18, 2023
Days to Decision 85 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code JWY — Manual Antimicrobial Susceptibility Test Systems
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640

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