FDA applicant

Sienna Biotech, Inc.

Columbia, MD3 decisions1996–19970 recalls

FDA records 3 decisions for Sienna Biotech, Inc. (Columbia, MD) from 1996 to 1997: 3 510(k) clearances. Most are in product codes LQN (Latex Agglutination Assay, Rubella) and LJO (Antigen, Iha, Cytomegalovirus). 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, microbiology panel, where it files most

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

FDA decisions per year

No FDA decision for Sienna Biotech, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sienna Biotech, 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 “Sienna”

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

Sienna Biopharmaceuticals, Inc. 1

Sienna Biotech, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Sienna”