K232892
- 510(k) number
- K232892
- Device name
- Hp Detect Stool Antigen ELISA
- Applicant
- Biomerica, Inc. CA · US
- Product code
- LYR — Helicobacter Pylori
- Decision date
- 2023-12-15
- Date received
- 2023-09-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K232892.pdf
Official FDA record: K232892
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.