K243284
- 510(k) number
- K243284
- Device name
- RELiZORB (100300/ 100301)
- Applicant
- Alcresta Therapeutics, Inc. MA · US
- Product code
- PLQ — Enzyme Packed Cartridge
- Decision date
- 2025-01-15
- Date received
- 2024-10-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243284.pdf
Official FDA record: K243284
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.