FDA applicant

Biotest Diagnostics Corp.

Denville, NJ5 decisions1996–19990 recalls

FDA records 5 decisions for Biotest Diagnostics Corp. (Denville, NJ) from 1996 to 1999: 5 510(k) clearances. Most are in product codes LSE (Epstein-Barr Virus, Other) and LIN (Antisera, Conjugated Fluorescent…). Its devices cite 4 predicates, 1 of them its own earlier devices. 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, microbiology panel, where it files most

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

FDA decisions per year

No FDA decision for Biotest Diagnostics Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Biotest Diagnostics Corp.’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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Other applicant names beginning “Biotest”

FDA records each applicant name separately; these may or may not be the same firm.

Biotest Medical Corp. 10 Biotest-Serum-Institut 2 Biotest Medizintechnik GmbH 1

Biotest Diagnostics Corp.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Biotest”