Data / Medical devices / United States / OriGen Biomedical, Inc.
OriGen Biomedical, Inc.: FDA-registered device maker in Austin, TX, United States, 1 510(k) clearance
OriGen Biomedical, Inc. is registered with the FDA (registration 3042484745) in Austin, TX, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 6, 2002. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3042484745
- Address
- 2215 Grand Avenue Pkwy, Austin, TX, United States, 78728
- Owner or operator
- ORIGEN BIOMEDICAL, INC. (9004483)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 6, 2007
- Registered through
- 2027
- Brand names listed
- Accessories, CryoStore Freezing Bag, CryoStore Multi-Chamber Bag, PermaLife® Cell Culture Bag, PermaLife® Cell Culture Bag, Evolve Cell Culture Bag, TissueVault Cell & Tissue Freezing Bag, O-Wrap Bag, Tube Sealer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, Empty, For Collection & Processing Of Blood & Blood Components | KSR | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Container, Frozen Donor Tissue Storage | LPZ | U | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Device, Heat-Sealing | KSD | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Flask, Tissue Culture | KJA | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tube, Tissue Culture | KJG | 1 | Complaint file establishment, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| August 6, 2002 | K021702 | CRYOBAG, MODEL CB | LPZ | Substantially Equivalent | Origen Biomedical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Container, Empty, For Collection & Processing Of Blood & Blood Components
- All makers of Device, Heat-Sealing
- All makers of Tube, Tissue Culture
- All makers of Flask, Tissue Culture
- All makers of Container, Specimen, Sterile
- All makers of Container, Frozen Donor Tissue Storage
Updated August 6, 2002. 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.