FDA applicant

Biovation, Inc.

Mchenry, IL11 decisions1978–19930 recalls

FDA records 11 decisions for Biovation, Inc. (Mchenry, IL) from 1978 to 1993: 11 510(k) clearances. Most are in product codes JQP (Calculator/Data Processing Module, For…) and 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, clinical chemistry panel, where it files most

How often FDA has decided Biovation, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biovation, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Biovation, Inc.’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

Biovation, Inc.

Which product codes does it file in?

What has FDA decided for it lately?