FDA 510(k)

IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)

K-Number: K260331 · 2026-09-04

ApplicantSiemens Healthcare Diagnostics Products, Ltd.

Decision Date2026-09-04

Product CodeDHB

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics Products, Ltd.. It received FDA 510(k) clearance on 2026-09-04 under 510(k) number K260331. The device is classified under product code DHB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)?

IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) is a medical device that received FDA 510(k) clearance on 2026-09-04. The listed applicant is Siemens Healthcare Diagnostics Products, Ltd.. The 510(k) number is K260331.

When did IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) receive FDA 510(k) clearance?

IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) received FDA 510(k) clearance on 2026-09-04, under 510(k) number K260331.

Who is the listed applicant for IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)?

The FDA 510(k) record lists Siemens Healthcare Diagnostics Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)?

The FDA product code for IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) is DHB.

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Other records listing Siemens Healthcare Diagnostics Products, Ltd. as applicant

K233946IMMULITE® 2000 BR-MA K213510IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA K203270IMMULITE/IMMULITE® 1000 Cortisol K202826IMMULITE® 2000 Cortisol

Related Devices (Code: DHB)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.