ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT— 510(k) K955266
Substantially EquivalentBoehringer Mannheim Italia Spa
FDA 510(k) clearance K955266 for ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT, Substantially Equivalent on 1996-02-29. 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.