510(k) Report

FDA applicant

Vanguard Biomedical Corp.

San Diego, CA10 decisions1988–19960 recalls

FDA records 10 decisions for Vanguard Biomedical Corp. (San Diego, CA) from 1988 to 1996: 10 510(k) clearances. Most are in product codes LCX (Kit, Test, Pregnancy, Hcg, Over The Counter) and CEP (Radioimmunoassay, Luteinizing Hormone). Its devices cite 1 predicate, 1 of them its own earlier devices. 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Vanguard Biomedical Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Vanguard Biomedical Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Vanguard”

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