FDA applicant

Liofilchem S. R. 1.

Roseto Degli Abruzzi, IT1 decision2020–20200 recalls

FDA records 1 decision for Liofilchem S. R. 1. (Roseto Degli Abruzzi, IT) in 2020: 1 510(k) clearance. All are in product code JWY (Manual Antimicrobial Susceptibility Test Systems). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Liofilchem S. R. 1.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Liofilchem S. R. 1. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Liofilchem S. R. 1.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Liofilchem”

FDA records each applicant name separately; these may or may not be the same firm.

Liofilchem s.r.l. 38

Liofilchem S. R. 1.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Liofilchem”