510(k) Report

FDA applicant

Gryphus Diagnostics, LLC

Rockville, MD2 decisions2000–20051 recall

FDA records 2 decisions for Gryphus Diagnostics, LLC (Rockville, MD) from 2000 to 2005: 2 510(k) clearances. All are in product code MXB (Test, Vaginal, Bacterial Sialidase). Its devices cite 3 predicates, 0 of them its own earlier devices. 1 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, microbiology panel, where it files most

How often FDA has decided Gryphus Diagnostics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gryphus Diagnostics, LLC since 2007.

Recalls per year

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • MXBTest, Vaginal, Bacterial Sialidase2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K050755Modification to BvblueGryphus Diagnostics, LLC · 20051 recall
  • K993732BvblueGryphus Diagnostics, LLC · 2000

All 2 as Gryphus Diagnostics, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K050755Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial VaginosisJan 9, 2024Class II