Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

IMMULITE® 2000 BR-MA

K-Number: K233946 · 2024-03-13

ApplicantSiemens Healthcare Diagnostics Products, Ltd.
Decision Date2024-03-13
Product CodeMOI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMULITE® 2000 BR-MA is a medical device manufactured by Siemens Healthcare Diagnostics Products, Ltd.. It received FDA 510(k) clearance on 2024-03-13 under approval number K233946. The device is classified under product code MOI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE® 2000 BR-MA?

IMMULITE® 2000 BR-MA is a medical device that received FDA 510(k) clearance on 2024-03-13. It is manufactured by Siemens Healthcare Diagnostics Products, Ltd.. The 510(k) number is K233946.

When was IMMULITE® 2000 BR-MA approved by the FDA?

IMMULITE® 2000 BR-MA received FDA 510(k) clearance on 2024-03-13, under approval number K233946.

What company makes IMMULITE® 2000 BR-MA?

IMMULITE® 2000 BR-MA is manufactured by Siemens Healthcare Diagnostics Products, Ltd..

What is the FDA product code for IMMULITE® 2000 BR-MA?

The FDA product code for IMMULITE® 2000 BR-MA is MOI.

Other Devices by Siemens Healthcare Diagnostics Products, Ltd.

K202826IMMULITE® 2000 Cortisol K203270IMMULITE/IMMULITE® 1000 Cortisol K213510IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA PMA P010053Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) PMA P010051Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) PMA P010050Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

View all 8 devices →

Related Devices (Code: MOI)

K181492Elecsys CA 15-3 IIRoche Diagnostics K171605Elecsys CA 15-3 IIRoche Diagnostics K192777ADVIA Centaur CA 15-3 assaySiemens Healthcare Diagnostics, Inc. K192524Lumipulse G CA15-3Fujirebio Diagnostics,Inc. K193489ADVIA Centaur BRSiemens Healthcare Diagnostics, Inc. K240403Access BR MonitorBeckman Coulter, Inc.

Official Source

View on FDA Database →

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

↑