FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT— 510(k) K000471
Substantially EquivalentFuture Diagnostics B.V.
FDA 510(k) clearance K000471 for FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT, Substantially Equivalent on 2000-04-11. Applicant: Future Diagnostics B.V..
Clearance details
- Applicant
- Future Diagnostics B.V.
- Product code
- Code CEW
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Adverse events under product code CEW
product code CEW- Malfunction
- 480
- Total
- 480
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.