510(k) K191973

Device: Lumpipulse G CA19-9-N
Applicant: Fujirebio Dianostics, Inc.
510(k) number: K191973
Product code: NIG
Decision: Substantially Equivalent (SESE)
Decision date: 2019-10-22
Date received: 2019-07-24
Regulation: 866.6010
Classification name: System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer
Medical specialty: Immunology
Review panel: Immunology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K231525	VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack	Ortho Clinical Diagnostics	2023-08-09
K200997	Lumipulse G CA19-9-N	Fujirebio Diagnostics,Inc.	2020-05-14
K100375	DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604	Siemens Healthcare Diagnostics, Inc.	2011-04-06
K052889	VITROS CA 19-9	Fujirebio Diagnostics,Inc.	2005-12-20
K052000	ARCHITECT CA 19-9XR ASSAY	Fujirebio Diagnostics,Inc.	2005-10-25
K033038	GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688	Beckman Coulter, Inc.	2003-12-29
K031393	BAYER ADVIA CENTAUR CA 19-9 ASSAY	Bayer Healthcare, LLC	2003-06-24
K023239	AIA-PACK CA 19-9	Tosoh Corp.	2002-12-23
K023240	ST AIA-PACK CA 19-9	Tosoh Corp.	2002-12-23
K020566	FUJIREBIO DIAGNOSTICS CA 19-9 RIA	Fujirebio Diagnostics,Inc.	2002-05-09

summary

Decision Summary