Data / Medical devices / United States / Babson Diagnostics
Babson Diagnostics: FDA-registered device maker in Austin, TX, United States, 2 510(k) clearances
Babson Diagnostics is registered with the FDA (registration 3028019212) in Austin, TX, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 1, 2023. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3028019212
- Address
- 1321 Rutherford Lane, Ste 200, Austin, TX, United States, 78753
- Owner or operator
- Babson Diagnostics (10089765)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 5, 2024
- Registered through
- 2026
- Brand names listed
- BD MiniDraw Capillary Tube Adapter SST, BD MiniDraw Capillary Tube Adapter Sysmex XN Only, BD MiniDraw Finger Sizing Tool, Babson Hand Warmer, Babson Sample Preparation Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Tubes, Vacuum Sample, With Anticoagulant | GIM | 2 | Repackager or relabeler | 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 1, 2023 | K230391 | BD MiniDraw Capillary Blood Collection System with BD MiniDraw SST Capillary Blood Collection Tube | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| November 27, 2023 | K230493 | BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube | GIM | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
Compare with other makers
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- All makers of Pad, Heating, Powered
- All makers of Tubes, Vacuum Sample, With Anticoagulant
Updated December 1, 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.