FDA applicant

Biotest-Serum-Institut

Mchenry, IL2 decisions1977–19810 recalls

FDA records 2 decisions for Biotest-Serum-Institut (Mchenry, IL) from 1977 to 1981: 2 510(k) clearances. Most are in product codes DGH (Igd, Peroxidase, Antigen, Antiserum, Control) and CAK (Microfilter, Blood Transfusion). 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, immunology panel, where it files most

How often FDA has decided Biotest-Serum-Institut’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biotest-Serum-Institut since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Biotest-Serum-Institut”

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

Biotest Medical Corp. 10 Biotest Diagnostics Corp. 5 Biotest Medizintechnik GmbH 1

Biotest-Serum-Institut

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Biotest-Serum-Institut”