DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692— 510(k) K081643
Substantially EquivalentSiemens Healthcare Diagnostics
FDA 510(k) clearance K081643 for DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692, Substantially Equivalent on 2008-07-03. Applicant: Siemens Healthcare Diagnostics.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics
- Product code
- Code MMI
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Newark, DE, US
Adverse events under product code MMI
product code MMI- Injury
- 172
- Malfunction
- 3,762
- Total
- 3,934
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.