FDA applicant

Biotest Medical Corp.

Taichung, TW10 decisions2009–20170 recalls

FDA records 10 decisions for Biotest Medical Corp. (Taichung, TW) from 2009 to 2017: 10 510(k) clearances. All are in product code NBW (System, Test, Blood Glucose, Over The Counter). Its devices cite 10 predicates, 8 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Biotest Medical Corporation”.

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

FIG. A — Illustration, clinical chemistry panel, where it files most

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

FDA decisions per year

2in 2017

2009high 3 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Biotest Medical Corp. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Biotest Medical Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Biotest”

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

Biotest Diagnostics Corp. 5 Biotest-Serum-Institut 2 Biotest Medizintechnik GmbH 1

Biotest Medical 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”