Monarch Blood Collection Set— 510(k) K232308
Substantially EquivalentThe Monarch Company
FDA 510(k) clearance K232308 for Monarch Blood Collection Set, Substantially Equivalent on 2023-12-04. Applicant: The Monarch Company.
Clearance details
- Applicant
- The Monarch Company
- Product code
- Code JKA
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Birmingham, AL, US
Adverse events under product code JKA
product code JKA- Injury
- 455
- Malfunction
- 26,686
- Other
- 4
- Total
- 27,145
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.