Data / Medical devices / United States / Labone, Inc.
Labone, Inc.: FDA-registered device maker in Lenexa, KS, United States, 1 510(k) clearance
Labone, Inc. is registered with the FDA (registration 1930987) in Lenexa, KS, United States. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 20, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1930987
- Address
- 10101 Renner Blvd, Lenexa, KS, United States, 66219
- Owner or operator
- LABONE, LLC., d/b/a Quest Diagnostics (9004417)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 6, 2001
- Registered through
- 2026
- Brand names listed
- Convenience Kit for Collecting and Transporting Upper Respiratory Specimens, Delayed Semen Analysis Media, HairCheck-DT (THC), QCard WHS, Quest Diagnostics Collection Kit for COVID-19 (Bulk & Activate), Quest Diagnostics Collection Kit for COVID-19 (Bulk), Quest Diagnostics Collection Kit for COVID-19 (Individual & Activate), Quest Diagnostics Collection Kit for COVID-19 (Individual) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Specification developer | accessdata.fda.gov |
| Container, Specimen Mailer And Storage, Sterile | KDT | 1 | Specification developer | accessdata.fda.gov |
| Covid-19 Test Home Collection Kit Devices | QLW | N | Specification developer | accessdata.fda.gov |
| Culture Media, Non-Selective And Non-Differential | JSG | 1 | Specification developer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Manufacturer | accessdata.fda.gov |
| Test, Cannabinoid, Employment And Insurance Testing, Exempt | PVJ | 2 | Manufacturer | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | 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 |
|---|---|---|---|---|---|---|
| December 20, 2023 | K230855 | BD Vacutainer® Serum Separator (SST) Blood Collection Tubes | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
Compare with other makers
- All makers of Container, Specimen Mailer And Storage, Non-Sterile
- All makers of Culture Media, Non-Selective And Non-Differential
- All makers of General Purpose Reagent
- All makers of Test, Cannabinoid, Employment And Insurance Testing, Exempt
- All makers of Covid-19 Test Home Collection Kit Devices
- All makers of Container, Specimen Mailer And Storage, Sterile
Updated December 20, 2023. 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.