DIGICLOT 2-#820— 510(k) K812121
Substantially EquivalentVolu Sol Medical Industries
FDA 510(k) clearance K812121 for DIGICLOT 2-#820, Substantially Equivalent on 1981-11-16. Applicant: Volu Sol Medical Industries.
Clearance details
- Applicant
- Volu Sol Medical Industries
- Product code
- Code JPA
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code JPA
product code JPA- Death
- 6
- Total
- 6
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.