510(k) K053073

Device: N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN
Applicant: DADE BEHRING, INC.
510(k) number: K053073
Product code: DEB
Decision: Substantially Equivalent (SESE)
Decision date: 2006-03-28
Date received: 2005-11-01
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: Summary
Third party reviewed: No

Applicant Contact#

Contact: KATHLEEN A DRAY-LYONS
Address: P.O. Box 6101 Newark DE US 19714 19714

FDA Registration Numbers#

3003749380
9610126
3003741796
3014325803
2050010
3012471076
9610806
9614373
2050012
3005452690
3019906

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DEB #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K140664	HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS	The Binding Site Group , Ltd.	2014-04-16
K081249	DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM	Dade Behring, Inc.	2008-07-21
K974564	IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT	Beckman Instruments, Inc.	1998-02-17
K914389	ALPHA-2 MACROGLOBULIN TEST RID KIT	The Binding Site, Ltd.	1991-12-20
K896483	QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK	Kallestad Diag, A Div. of Erbamont, Inc.	1989-12-01
K850683	72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2	Kent Laboratories, Inc.	1985-11-27
K851282	RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI	Cooper Biomedical, Inc.	1985-05-24
K850603	SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN	Applications Lab	1985-03-05
K812493	IMMUNOGL. FRCT. OF RABBIT ANTISER.-MACRO	Dako Corp.	1981-09-23
K791340	HUMAN ALPHA2 MACROGLOBULIN	Beckman Instruments, Inc.	1979-08-16
K772246	ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY	Kallestad Laboratories, Inc.	1977-12-22
K771780	LAS-R TM	Hyland Therapeutic Div., Travenol Laboratories	1977-10-04

Legacy Summary#

summary

FDA Review#

Decision Summary