Data / Medical devices / United States / TMRW LIFE SCIENCES, Inc.
TMRW LIFE SCIENCES, Inc.: FDA-registered device maker in New York, NY, United States, 1 510(k) clearance
TMRW LIFE SCIENCES, Inc. is registered with the FDA (registration 3025301749) in New York, NY, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 4, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025301749
- Address
- 250 Hudson Street Suite 102, New York, NY, United States, 10013
- Owner or operator
- TMRW Life Sciences, Inc. (10086637)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- November 28, 2022
- Registered through
- 2026
- Brand names listed
- CryoBeacon, CryoRobot Select, CryoTransporter, TMRW Vault
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Assisted Reproduction, Exempt | PUB | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Automated Cryopreservation Storage System | QUJ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 4, 2022 | K221086 | CryoRobot Select System | QUJ | Substantially Equivalent | Tmrw Life Sciences, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Automated Cryopreservation Storage System
- All makers of Accessory, Assisted Reproduction, Exempt
Updated November 4, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.