510(k) Report

FDA applicant

Bioscientific

Mchenry, IL16 decisions1978–19810 recalls

FDA records 16 decisions for Bioscientific (Mchenry, IL) from 1978 to 1981: 16 510(k) clearances. Most are in product codes HZJ (Stain, Papanicolau) and JPK (Mixture, Hematology Quality Control). 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 Bioscientific’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bioscientific since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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