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510(k) K914389

Device
Alpha-2 Macroglobulin Test Rid Kit
Applicant
THE BINDING SITE, LTD.
510(k) number
K914389
Product code
DEB
Decision
Substantially Equivalent (SESE)
Decision date
1991-12-20
Date received
1991-10-01
Regulation
866.5620
Classification name
Alpha-2-Macroglobulin, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JAY H GELLER
Address
Westside Towers, Suite 1000 11845 W. Olympic Blvd. Los Angeles CA US 90064 90064

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DEB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K140664HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUSThe Binding Site Group , Ltd.2014-04-16
K081249DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEMDade Behring, Inc.2008-07-21
K053073N ANTISERA TO HUMAN ALPHA2-MACROGLOBULINDade Behring, Inc.2006-03-28
K974564IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENTBeckman Instruments, Inc.1998-02-17
K896483QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.1989-12-01
K85068372 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2Kent Laboratories, Inc.1985-11-27
K851282RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULICooper Biomedical, Inc.1985-05-24
K850603SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULINApplications Lab1985-03-05
K812493IMMUNOGL. FRCT. OF RABBIT ANTISER.-MACRODako Corp.1981-09-23
K791340HUMAN ALPHA2 MACROGLOBULINBeckman Instruments, Inc.1979-08-16
K772246ALPHA-2-MACROGLOBULIN NEPHEL. ASSAYKallestad Laboratories, Inc.1977-12-22
K771780LAS-R TMHyland Therapeutic Div., Travenol Laboratories1977-10-04