GAP IGG H.PYLORI MODIFIED— 510(k) K915185

Name: FDA 510(k) clearance K915185
Creator: U.S. Food and Drug Administration
Published: 1992-03-04

Substantially Equivalent

Biomerica, Inc.

FDA 510(k) clearance K915185 for GAP IGG H.PYLORI MODIFIED, Substantially Equivalent on 1992-03-04. Applicant: Biomerica, Inc.. Device class: 1.

Clearance details

Applicant: Biomerica, Inc.
Product code: Code LYR
Device class: Class 1
Regulation: 21 CFR 866.3110
Advisory panel: Microbiology
Date received: 1991-11-18
Decision date: 1992-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newport Beach, 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.