RELiZORB (100300/ 100301)— 510(k) K243284

Substantially Equivalent

Alcresta Therapeutics, Inc.

FDA 510(k) clearance K243284 for RELiZORB (100300/ 100301), Substantially Equivalent on 2025-01-15. Applicant: Alcresta Therapeutics, Inc..

Clearance details

Applicant: Alcresta Therapeutics, Inc.
Product code: Code PLQ
Advisory panel: Gastroenterology, Urology
Date received: 2024-10-17
Decision date: 2025-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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