FDA.reportPublic FDA data

510(k) K860138

Device
No. 615 Determination Of Ceruloplasmin In Serum
Applicant
SIGMA DIAGNOSTICS, INC.
510(k) number
K860138
Product code
DDB
Decision
Substantially Equivalent (SESE)
Decision date
1986-03-28
Date received
1986-01-14
Regulation
866.5210
Classification name
Ceruloplasmin, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LEO BRESSLER
Address
P.O. Box 14508 St. Louis MO US 63178 63178

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DDB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K161508CeruloplasminBeckman Coulter Ireland, Inc.2017-01-09
K122965HUMAN CAERULOPLASMIN KITThe Binding Site Group , Ltd.2013-06-03
K053074N ANTISERA TO HUMAN CERULOPLASMINDade Behring, Inc.2006-03-16
K964762IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENTBeckman Instruments, Inc.1997-04-25
K913668CAERULOPLASMIN IMMUNOLOGICAL NL TEST KITThe Binding Site, Ltd.1991-12-20
K895377QM300 CERULOPLASMIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.1989-09-21
K85068272 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPLKent Laboratories, Inc.1985-11-25
K852247LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS)Behring Diagnostics, Inc.1985-07-10
K851283RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMINCooper Biomedical, Inc.1985-05-23
K823107QUANTIMETRIC 2 CERULOPLASMIN ASSAYKallestad Laboratories, Inc.1982-11-16
K812486IMMUNOGL. FRCT. OF RABBIT ANTISER.-CERULDako Corp.1981-09-23
K801661J.T. BAKER CERULOPLASMIN NEPHELOMETRICJ.T. Baker Chemical Co.1980-09-16
K790712ANTISERUM TO HUMAN, ALPHA-2-MACROGLOBULIKent Laboratories, Inc.1979-08-16
K790714ANTISERUM TO HUMAN CERULOPLASMINKent Laboratories, Inc.1979-08-16
K791339HUMAN CERULOPLASMINBeckman Instruments, Inc.1979-08-16