LABORATORY DATA MGMT SYSTEM SDMS— 510(k) K831838
Substantially EquivalentVickers America Medical Corp.
FDA 510(k) clearance K831838 for LABORATORY DATA MGMT SYSTEM SDMS, Substantially Equivalent on 1984-01-24. Applicant: Vickers America Medical Corp..
Clearance details
- Applicant
- Vickers America Medical Corp.
- Product code
- Code JQP
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Adverse events under product code JQP
product code JQP- Death
- 3
- Malfunction
- 690
- Total
- 693
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.