FDA.reportPublic FDA data

Alcresta Therapeutics, Inc.

Matched from indexed company URL: Alcresta, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30095966663009596666Alcresta Therapeutics, Inc.1N2026-01-01130 Turner Street Building 3, Suite 200 Waltham MA US 02453

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00862205000205Relizorb - Enzyme Packed Cartridge6177149946rwagner@alcresta.com
00862205000212RELiZORB - Enzyme Packed Cartridge with ENFit.6177149946rwagner@alcresta.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1894231535044730K250499RELiZORB (100300/100301)PLQ2025-04-17
1894231219967699K243284RELiZORB (100300/ 100301)PLQ2025-01-15
1894231875152707K232784RELiZORB®PLQ2023-12-21
1894231420410556DEN150001RELIZORBPLQ2015-11-20

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PLQ42025-04-17

PMN#

RELiZORB

2019-12-04

Alcresta Therapeutics, Inc.

Relizorb

2017-07-12

Alcresta Therapeutics, Inc.

Relizorb

2016-06-30

Alcresta Therapeutics, Inc.

GUDID#