IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT— 510(k) K090257
Substantially EquivalentSiemens Healthcare Diagnostics
FDA 510(k) clearance K090257 for IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, Substantially Equivalent on 2009-05-26. Applicant: Siemens Healthcare Diagnostics. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics
- Product code
- Product code DHB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5750
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.