FDA.reportPublic FDA data

510(k) K771780

Device
LAS-R TM
Applicant
Hyland Therapeutic Div., Travenol Laboratories
510(k) number
K771780
Product code
DEB
Decision
Substantially Equivalent (SESE)
Decision date
1977-10-04
Date received
1977-09-23
Regulation
866.5620
Classification name
Alpha-2-Macroglobulin, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Third party reviewed
N

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K914389ALPHA-2 MACROGLOBULIN TEST RID KITThe Binding Site, Ltd.1991-12-20
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