FDA applicant

Inovar Biologicals, Inc.

Gaithersburg, MD1 decision1989–19890 recalls

FDA records 1 decision for Inovar Biologicals, Inc. (Gaithersburg, MD) in 1989: 1 510(k) clearance. All are in product code KIT (Media And Components, Synthetic Cell And…). 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 Inovar Biologicals, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Inovar Biologicals, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Inovar Biologicals, Inc.

Which product codes does it file in?

What has FDA decided for it lately?