510(k) Report

FDA applicant

Accra Laboratories, Inc.

Mchenry, IL20 decisions1981–19850 recalls

FDA records 20 decisions for Accra Laboratories, Inc. (Mchenry, IL) from 1981 to 1985: 20 510(k) clearances. Most are in product codes IAF (Wright'S Stain) and JTS (Stains, Microbiologic). 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 Accra Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Accra Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Accra Laboratories, Inc.’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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