IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT— 510(k) K083314
Substantially EquivalentSiemens Healthcare Diagnostics
FDA 510(k) clearance K083314 for IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, Substantially Equivalent on 2009-03-11. Applicant: Siemens Healthcare Diagnostics.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics
- Product code
- Code DHB
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.