Data / Medical devices / United States / Supera Fulfillment LLC
Supera Fulfillment LLC: FDA-registered device maker in Houston, TX, United States, 1 510(k) clearance
Supera Fulfillment LLC is registered with the FDA (registration 3018077536) in Houston, TX, United States. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 7, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018077536
- Address
- 3240 Fuqua St Ste 3246, Houston, TX, United States, 77047
- Owner or operator
- Supera Fulfillment LLC (10080816)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- February 26, 2021
- Registered through
- 2026
- Brand names listed
- Cobas, Copan, GlutenID Celiac Genetic Health Risk Test, Supera Blood Collection Convenience Kit, Professional Use
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | 2 | Manufacturer | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Culture Media, Non-Selective And Non-Differential | JSG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Genetic Variant Detection And Health Risk Assessment System | PTA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Ph Buffer | JCC | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| January 7, 2025 | K241456 | GlutenID Celiac Genetic Health Risk Test | PTA | Substantially Equivalent | Targeted Genomics, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Container, Specimen, Sterile
- All makers of Applicator, Absorbent Tipped, Sterile
- All makers of Ph Buffer
- All makers of Genetic Variant Detection And Health Risk Assessment System
- All makers of Container, Specimen Mailer And Storage, Non-Sterile
- All makers of Blood Specimen Collection Convenience Kit (Excludes Hiv)
Updated January 7, 2025. 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.