510(k) Report

FDA applicant

Stellar Bio Systems, Inc.

Columbia, MD7 decisions1988–19990 recalls

FDA records 7 decisions for Stellar Bio Systems, Inc. (Columbia, MD) from 1988 to 1999: 7 510(k) clearances. Most are in product codes GQH (Antigen, Cf (Including Cf Control)…) and GQL (Antisera, Fluorescent, Herpesvirus Hominis 1,2). 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 Stellar Bio Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Stellar Bio Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Stellar Bio Systems, Inc.’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 “Stellar”

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