RAPIDVUE HCG TEST— 510(k) K102175
Substantially EquivalentQuidel Corporation
FDA 510(k) clearance K102175 for RAPIDVUE HCG TEST, Substantially Equivalent on 2010-08-25. Applicant: Quidel Corporation.
Clearance details
- Applicant
- Quidel Corporation
- Product code
- Code JHI
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Diego, CA, US
Adverse events under product code JHI
product code JHI- Malfunction
- 1,055
- Total
- 1,055
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.