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510(k) K234052

Device
Access Ferritin
Applicant
Beckman Coulter, Inc.
510(k) number
K234052
Product code
JMG
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-20
Date received
2023-12-21
Regulation
866.5340
Classification name
Radioimmunoassay (Two-Site Solid Phase), Ferritin
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kate Oelberg
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 JMG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K052082FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020Beckman Coulter, Inc.2005-08-19
K964282TINA-QUANT FERRITIN ASSAYBoehringer Mannheim Corp.1997-07-30
K971833ELECSYS FERRITINBoehringer Mannheim Corp.1997-06-02
K963498FERR FLEX REAGENT CARTRIDGEDade Chemistry Systems, Inc.1997-01-24
K950393ACE(TM) CEDIA(R) FERRITIN ASSAYSchiapparelli Biosystems, Inc.1995-05-16
K926221ACCESS FERRITIN ASSAYBio-Rad Laboratories, Inc.1993-01-13
K925848IMMULITE FERRITINDiagnostic Products Corp.1993-01-13
K920829COBAS CORE FERRITIN EIARoche Diagnostic Systems, Inc.1992-06-19
K920318CEDIA FERRITIN ASSAYMicrogenics Corp.1992-06-04
K902997MILENIA (TM) FERRITINDiagnostic Products Corp.1990-08-02
K890697RIA-GNOST FERRITINCambridge Medical Technology1989-03-16
K881138CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO.Baxter Healthcare Corp1988-04-21
K873730MEDIX BIOTECH FERRITIN ENZYME IMMUNOASSAY TEST KITMedix Biotech, Inc.1987-11-04
K872955DELFIA(TM) FERRITIN KITLkb Instruments, Inc.1987-08-21
K840460CORNINGS MAGIC FERRITIN RADIOIMMUNO-Corning Medical & Scientific1984-03-30