FDA applicant

Guardian Scientific, Corp.

Columbia, MD4 decisions1995–19970 recalls

FDA records 4 decisions for Guardian Scientific, Corp. (Columbia, MD) from 1995 to 1997: 4 510(k) clearances. Most are in product codes GMQ (Antigens, Nontreponemal, All) 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, microbiology panel, where it files most

How often FDA has decided Guardian Scientific, Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Guardian Scientific, Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Guardian Scientific, Corp.’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 “Guardian”

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

Guardian Products Co., Inc. 8 Guardian Angel Products, Inc. 5 Guardian Group, Inc. 2 Guardian Chemical 2

Guardian Scientific, Corp.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Guardian”