---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-23-033030"
form_type: "8-K"
ticker: "BMRA"
cik: "0000073290"
company_name: "BIOMERICA INC"
filed_at: "2023-09-19T23:59:59+00:00"
generated_at: "2026-06-10T14:13:19.376628+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Biomerica submits final H. pylori dataset to FDA for 510(k) review of hp+detect test

## Summary
- Submitted final H. pylori data-set to FDA on Sep 15, 2023, as requested during FDA's 510(k) review.
- FDA confirmed receipt of the data; Biomerica's hp+detect test detects H. pylori bacteria.
- H. pylori infects approximately 35% of the U.S. population.

## SEC filing metadata
- accession: 0001493152-23-033030
- form_type: 8-K
- ticker: BMRA
- cik: 0000073290
- company_name: BIOMERICA INC
- filed_at: 2023-09-19T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/73290/000149315223033030/0001493152-23-033030-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/73290/000149315223033030/form8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-23-033030
- JSON: https://secwatch.observer/filing/0001493152-23-033030.json
- Plain text: https://secwatch.observer/filing/0001493152-23-033030.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.