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510(k) K033038

Device
GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688
Applicant
BECKMAN COULTER, INC.
510(k) number
K033038
Product code
NIG  
Decision
Substantially Equivalent (SESE)
Decision date
2003-12-29
Date received
2003-09-29
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#

Contact
BRENT TABER
Address
1000 Lake Hazeltine Dr. Chaska MN US 55318 55318

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NIG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K231525VITROS Immunodiagnostic Products CA 19-9TM Reagent PackOrtho Clinical Diagnostics2023-08-09
K200997Lumipulse G CA19-9-NFujirebio Diagnostics,Inc.2020-05-14
K191973Lumpipulse G CA19-9-NFujirebio Dianostics, Inc.2019-10-22
K100375DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604Siemens Healthcare Diagnostics, Inc.2011-04-06
K052889VITROS CA 19-9Fujirebio Diagnostics,Inc.2005-12-20
K052000ARCHITECT CA 19-9XR ASSAYFujirebio Diagnostics,Inc.2005-10-25
K031393BAYER ADVIA CENTAUR CA 19-9 ASSAYBayer Healthcare, LLC2003-06-24
K023239AIA-PACK CA 19-9Tosoh Corp.2002-12-23
K023240ST AIA-PACK CA 19-9Tosoh Corp.2002-12-23
K020566FUJIREBIO DIAGNOSTICS CA 19-9 RIAFujirebio Diagnostics,Inc.2002-05-09

Legacy Summary#

summary

FDA Review#

Decision Summary