FDA applicant

Humagen Fertility Diagnostics, Inc.

Charlottesville, VA5 decisions1994–20023 recalls

FDA records 5 decisions for Humagen Fertility Diagnostics, Inc. (Charlottesville, VA) from 1994 to 2002: 5 510(k) clearances. Most are in product codes MQH (Microtools, Assisted Reproduction (Pipettes)) and MQK (Labware, Assisted Reproduction). Its devices cite 1 predicate, 1 of them its own earlier devices. 3 recalls are linked to its devices.

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

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Humagen Fertility Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Humagen Fertility Diagnostics, Inc. since 2007.

Recalls per year

1in 2019

2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Humagen”

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

Humagen, Inc. 1

Humagen Fertility Diagnostics, 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?

What has been recalled?

Other applicant names beginning “Humagen”