FDA applicant

Saliva Diagnostic Systems, Inc.

Vancouver, WA3 decisions1995–19980 recalls

FDA records 3 decisions for Saliva Diagnostic Systems, Inc. (Vancouver, WA) from 1995 to 1998: 3 510(k) clearances. Most are in product codes LYR (Helicobacter Pylori) and LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). No recall is linked to its devices.

FDA’s records also spell it “Saliva Diagnostic Systems”.

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 Saliva Diagnostic Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Saliva Diagnostic Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Saliva Diagnostic 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

Saliva Diagnostic Systems, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?