QUANTA LITE H. PYLORI IGG ELISA— 510(k) K982790

Name: FDA 510(k) clearance K982790
Creator: U.S. Food and Drug Administration
Published: 1998-11-04

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K982790 for QUANTA LITE H. PYLORI IGG ELISA, Substantially Equivalent on 1998-11-04. Applicant: Inova Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code LYR
Device class: Class 1
Regulation: 21 CFR 866.3110
Advisory panel: Microbiology
Date received: 1998-08-10
Decision date: 1998-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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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.