Data / Medical devices / United States / Collaborative Care Diagnostics LLC dba BioMedix
Collaborative Care Diagnostics LLC dba BioMedix: FDA-registered device maker in Eagan, MN, United States, 2 510(k) clearances
Collaborative Care Diagnostics LLC dba BioMedix is registered with the FDA (registration 2134492) in Eagan, MN, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 20, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2134492
- FEI number
- 3002619777
- Address
- 860 Blue Gentian Rd Ste 195, Eagan, MN, United States, 55121
- Owner or operator
- Collaborative Care Diagnostics, LLC dba BioMedix (10044691)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- July 15, 2013
- Registered through
- 2026
- Brand names listed
- PADnet 2, PADnet Read, PADnet Xpress
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medical Device Data System | OUG | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | JOM | 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 |
|---|---|---|---|---|---|---|
| October 20, 2022 | K220527 | PADnet Xpress | JOM | Substantially Equivalent | Collaborative Care Diagnostics, LLC, D.B.A. Biomedix | accessdata.fda.gov |
| August 29, 2012 | K122281 | PADNET 2.0 | JOM | Substantially Equivalent | Biomedix, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
- All makers of Medical Device Data System
Updated October 20, 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.