Cleared Traditional

Sulopenem SPM 2 ?g

K251879 · Liofilchem · Microbiology

Aug 2025

Decision

55d

Days

Class 2

Risk

About This 510(k) Submission

K251879 is an FDA 510(k) clearance for the Sulopenem SPM 2 ?g, a Susceptibility Test Discs, Antimicrobial (Class II — Special Controls, product code JTN), submitted by Liofilchem (Waltham, US). The FDA issued a Cleared decision on August 12, 2025, 55 days after receiving the submission on June 18, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number	K251879 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 18, 2025
Decision Date	August 12, 2025
Days to Decision	55 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement