FDA applicant

Germaine Laboratories, Inc.

San Antonio, TX8 decisions1997–20050 recalls

FDA records 8 decisions for Germaine Laboratories, Inc. (San Antonio, TX) from 1997 to 2005: 8 510(k) clearances. Most are in product codes DHA (System, Test, Human Chorionic Gonadotropin) and JHI (Visual, Pregnancy Hcg, Prescription Use). 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, clinical chemistry panel, where it files most

How often FDA has decided Germaine Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Germaine Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Germaine Laboratories, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?