EVENT TEST STRIP HCG— 510(k) K935502
Substantially EquivalentBoehringer Mannheim Italia Spa
FDA 510(k) clearance K935502 for EVENT TEST STRIP HCG, Substantially Equivalent on 1994-01-27. Applicant: Boehringer Mannheim Italia Spa.
Clearance details
- Applicant
- Boehringer Mannheim Italia Spa
- Product code
- Code JHI
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Simi Valley, 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.