Hp Detect Stool Antigen ELISA— 510(k) K232892

Substantially Equivalent

Biomerica, Inc.

FDA 510(k) clearance K232892 for Hp Detect Stool Antigen ELISA, Substantially Equivalent on 2023-12-15. Applicant: Biomerica, Inc..

Clearance details

Applicant: Biomerica, Inc.
Product code: Code LYR
Advisory panel: Microbiology
Date received: 2023-09-18
Decision date: 2023-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.