Source document or public record
FDA 510(k) K200180 — MTS Omadacycline 0.002 - 32 ug/mL
FDA 510(k) index record K200180. Device: MTS Omadacycline 0.002 - 32 ug/mL. Applicant as listed: Liofilchem s.r.l.. Decision date: 2020-03-20.
Source
"device_name": "MTS Omadacycline 0.002 - 32 ug/mL"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K200180.
Device name: MTS Omadacycline 0.002 - 32 ug/mL. Applicant as listed: Liofilchem s.r.l..
Decision date: 2020-03-20. Decision wording: Substantially Equivalent.
Product code: JWY. Regulation: 21 CFR 866.1640. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
Interested in these solutions?
Submit a sourcing request with the assays, volumes, and timeline of your own project.