FDA applicant

Liofilchem s.r.l.

Roseto Degli Abruzzi, IT38 decisions2016–20260 recalls

FDA records 38 decisions for Liofilchem s.r.l. (Roseto Degli Abruzzi, IT) from 2016 to 2026: 38 510(k) clearances. Most are in product codes JWY (Manual Antimicrobial Susceptibility Test Systems) and JTN (Susceptibility Test Discs, Antimicrobial). Since 2016 its 510(k)s took a median of 62 days from receipt to decision, against 61 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Liofilchem, Inc.”, “Liofilchem”.

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.l.’s devices, and how often a recall has named them.

FDA decisions per year

5in 2025

2016high 9 (2018) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Liofilchem s.r.l. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Other applicant names beginning “Liofilchem”

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

Liofilchem S. R. 1. 1

Liofilchem s.r.l.

Which product codes does it file in?

How long do its 510(k) reviews take?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Liofilchem”