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Immulite® 2000 Br-Ma

by Siemens Healthcare Diagnostics Products Ltd

510(k) K233946

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK233946 Date13 Mar 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MOI
FDA applicant
Siemens Healthcare Diagnostics Products, Ltd.
Device class
Class II
Regulation
21 CFR Part 866.6010
Advisory committee
Immunology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The IMMULITE 2000 BR-MA is an immunological test system used for antigen and tumor testing. It is part of the IMMULITE 2000 XPi Immunoassay System, which provides versatility for specialty testing demands.

The device is manufactured by Siemens Healthcare Diagnostics Products, Ltd. and has FDA 510(k) clearance with the K233946 number. It is a Class II device regulated under product code MOI and is intended for use in immunology testing.

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Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the IMMULITE 2000 BR-MA used for?

    The IMMULITE 2000 BR-MA is an immunological test system designed for antigen and tumor testing. It is part of the IMMULITE 2000 XPi Immunoassay System, which provides versatility for specialty testing demands in immunology.

  • What is the regulatory status of the IMMULITE 2000 BR-MA?

    The IMMULITE 2000 BR-MA has FDA 510(k) clearance with the K233946 number. It is classified as a Class II device under product code MOI and is intended for use in immunology testing.

  • How is the IMMULITE 2000 BR-MA supplied?

    The device is manufactured by Siemens Healthcare Diagnostics Products, Ltd. and is part of the IMMULITE 2000 XPi Immunoassay System. Specific details about supply configurations, packaging, or quantities are not provided in the available information.

  • What are the specifications of the IMMULITE 2000 BR-MA?

    The IMMULITE 2000 BR-MA is an immunological test system with FDA 510(k) clearance K233946. It is a Class II device under product code MOI, intended for immunology testing. The device is part of the IMMULITE 2000 XPi platform, which offers versatility for specialty testing demands.