Sulopenem SPM 2 µg

FDA 510(k) K251879 · Liofilchem

Substantially Equivalent

510(k) numberK251879

Submission

Device name
Sulopenem SPM 2 µg
Applicant
Liofilchem
Waltham, MA, US
Received
June 18, 2025
Decision date
August 12, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JTN – Susceptibility Test Discs, Antimicrobial
Device class
Class II (moderate risk)
Regulation
21 CFR 866.1620
Specialty
Microbiology

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More from Hardy Diagnostics

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K250885Ceftobiprole BPR 5 µg DiscJTN · Traditional 06/23/2025SE

Questions and answers

When was Sulopenem SPM 2 µg cleared by the FDA?

Sulopenem SPM 2 µg (K251879) received a 510(k) decision of Substantially Equivalent on August 12, 2025, 55 days after the submission was received.

What is the product code of K251879?

The FDA product code is JTN – Susceptibility Test Discs, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1620.