K232308
- 510(k) number
- K232308
- Device name
- Monarch Blood Collection Set
- Applicant
- The Monarch Company AL · US
- Product code
- JKA — Tubes, Vials, Systems, Serum Separators, Blood Colle
- Decision date
- 2023-12-04
- Date received
- 2023-08-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K232308.pdf
Official FDA record: K232308
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.