IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY— 510(k) K132801
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K132801 for IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY, Substantially Equivalent on 2014-05-28. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- 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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