STAT-SIMPLE PYLORI— 510(k) K980782

Substantially Equivalent

Saliva Diagnostic Systems, Inc.

FDA 510(k) clearance K980782 for STAT-SIMPLE PYLORI, Substantially Equivalent on 1998-08-05. Applicant: Saliva Diagnostic Systems, Inc..

Clearance details

Applicant: Saliva Diagnostic Systems, Inc.
Product code: Code LYR
Advisory panel: Microbiology
Date received: 1998-03-02
Decision date: 1998-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver, WA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LYR

product code LYR

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.