FDA applicant

Intracel Corp.

Rockville, MD5 decisions1995–20002 recalls

FDA records 5 decisions for Intracel Corp. (Rockville, MD) from 1995 to 2000: 5 510(k) clearances. Most are in product codes LLH (Reagents, Clostridium Difficile Toxin) and GNW (Antisera, Cf, Influenza Virus A, B, C). Its devices cite 2 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

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

FDA decisions per year

No FDA decision for Intracel Corp. since 2007.

Recalls per year

1in 2025

2007high 1 (2021) · low 0 (2007)2026

Class I Class II/III not classified

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

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Intracel Corp.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?