510(k) Report

FDA applicant

Interlab S.R.L.

East Stroudsburg, PA4 decisions2003–20060 recalls

FDA records 4 decisions for Interlab S.R.L. (East Stroudsburg, PA) from 2003 to 2006: 4 510(k) clearances. Most are in product codes JBD (System, Analysis, Electrophoretic Hemoglobin) and GKA (Abnormal Hemoglobin Quantitation). 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Interlab S.R.L. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Interlab S.R.L. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Interlab”

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