IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6— 510(k) K091984
Substantially EquivalentSiemens Medical Solutions Diagnostics
FDA 510(k) clearance K091984 for IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6, Substantially Equivalent on 2009-10-28. Applicant: Siemens Medical Solutions Diagnostics. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions Diagnostics
- 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
- Los Angeles, CA, US
Recent devices under product code DHB
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Data sourced from openFDA. This site is unofficial and independent of the FDA.