Data / Medical devices / United States / The Monarch Company, LLC
The Monarch Company, LLC: FDA-registered device maker in Birmingham, AL, United States, 1 510(k) clearance
The Monarch Company, LLC is registered with the FDA (registration 3030243919) in Birmingham, AL, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 4, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030243919
- Address
- 2700 Corporate Dr Ste 200, Birmingham, AL, United States, 35242
- Owner or operator
- The Monarch company, LLC (10089652)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 26, 2023
- Registered through
- 2026
- Brand names listed
- Monarch Safety Blood Collection set, The Monarch safety Blood Collection Set
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Blood Collection, Vacuum-Assisted, Manual | KST | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 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 |
|---|---|---|---|---|---|---|
| December 4, 2023 | K232308 | Monarch Blood Collection Set | JKA | Substantially Equivalent | The Monarch Company | accessdata.fda.gov |
Compare with other makers
- All makers of System, Blood Collection, Vacuum-Assisted, Manual
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
Updated December 4, 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.