IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)— 510(k) K260331
Substantially EquivalentSiemens Healthcare Diagnostics Products, Ltd.
FDA 510(k) clearance K260331 for IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13), Substantially Equivalent on 2026-09-04. Applicant: Siemens Healthcare Diagnostics Products, Ltd.. Device class: 2.
Summary
Siemens Healthcare Diagnostics' clearance covers two IMMULITE 2000 items: 3gAllergy Specific IgE Vantage and a Peanut Allergen (F13). Product code DHB is radioallergosorbent (RAST) immunological test systems.
Class II, 21 CFR 866.5750. Immunology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Siemens filed from Llanberis, United Kingdom. The decision came 214 calendar days after FDA received it (February 2 to September 4, 2026).
Clearance details
- Applicant
- Siemens Healthcare Diagnostics Products, Ltd.
- 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
- Llanberis, GB
Recent devices under product code DHB
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