FDA 510(k)

Lumipulse G CA15-3

K-Number: K192524 · 2020-09-04

Decision Date2020-09-04

Product CodeMOI

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

Lumipulse G CA15-3 is a medical device manufactured by Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2020-09-04 under approval number K192524. 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 Lumipulse G CA15-3?

Lumipulse G CA15-3 is a medical device that received FDA 510(k) clearance on 2020-09-04. It is manufactured by Fujirebio Diagnostics,Inc.. The 510(k) number is K192524.

When was Lumipulse G CA15-3 approved by the FDA?

Lumipulse G CA15-3 received FDA 510(k) clearance on 2020-09-04, under approval number K192524.

What company makes Lumipulse G CA15-3?

Lumipulse G CA15-3 is manufactured by Fujirebio Diagnostics,Inc..

What is the FDA product code for Lumipulse G CA15-3?

The FDA product code for Lumipulse G CA15-3 is MOI.

Other Devices by Fujirebio Diagnostics,Inc.

K163053Lumipulse G E2-III Calibrators K153145Lumipulse G TP-N Immunoreaction Cartridge Set K160090Lumipulse G ROMA K151502ARCHITECT ROMA K153361Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators K172713Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS PCT Calibrators set

View all 18 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. K193489ADVIA Centaur BRSiemens Healthcare Diagnostics, Inc. K240403Access BR MonitorBeckman Coulter, Inc. K233946IMMULITE® 2000 BR-MASiemens Healthcare Diagnostics Products, Ltd.

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.