510(k) Report

FDA applicant

Melet Schloesing Laboratories USA

San Diego, CA2 decisions2005–20050 recalls

FDA records 2 decisions for Melet Schloesing Laboratories USA (San Diego, CA) in 2005: 2 510(k) clearances. All are in product code GKZ (Counter, Differential Cell). 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 Melet Schloesing Laboratories USA’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Melet Schloesing Laboratories USA since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Melet Schloesing Laboratories USA by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Melet Schloesing Laboratories USA’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