FDA applicant

Biotest Medizintechnik GmbH

Richmond, VA1 decision2002–20020 recalls

FDA records 1 decision for Biotest Medizintechnik GmbH (Richmond, VA) in 2002: 1 510(k) clearance. All are in product code GKR (System, Hemoglobin, Automated). 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 Biotest Medizintechnik GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biotest Medizintechnik GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biotest Medizintechnik GmbH 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”

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

Biotest Medical Corp. 10 Biotest Diagnostics Corp. 5 Biotest-Serum-Institut 2

Biotest Medizintechnik GmbH

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Biotest”