JZG · Class II · 21 CFR 866.5630

FDA Product Code JZG: System, Test, Beta-2-microglobulin Immunological

Leading manufacturers include The Binding Site, Ltd., Pharmacia, Inc. and Diagnostic Products Corp..

53
Total
53
Cleared
124d
Avg days
1984
Since

FDA 510(k) Cleared System, Test, Beta-2-microglobulin Immunological Devices (Product Code JZG)

53 devices
1–24 of 53
Cleared Aug 30, 2012
HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS
K122066
The Binding Site Group , Ltd.
Immunology · 45d
Cleared Jan 20, 2012
ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR
K110874
Siemens Healthcare Diagnostics, Inc.
Immunology · 297d
Cleared May 06, 2009
HUMAN BETA-2 MICROGLOBULIN KIT
K083289
The Binding Site, Ltd.
Immunology · 180d
Cleared Mar 13, 2009
DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M
K083463
Siemens Healthcare Diagnostics
Immunology · 109d
Cleared Jan 26, 2007
DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH
K063272
Dade Behring, Inc.
Immunology · 88d
Cleared Aug 15, 2002
MININEPH HUMAN B2-MICROGLOBULIN KIT
K014270
The Binding Site, Ltd.
Immunology · 231d
Cleared Nov 20, 2000
N LATEX B2-MICROGLOBULIN
K002731
Dade Behring, Inc.
Immunology · 80d
Cleared Dec 16, 1999
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS)
K993711
Bayer Corp.
Chemistry · 43d
Cleared May 11, 1999
B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM
K991136
Olympus America, Inc.
Immunology · 36d
Cleared Nov 25, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT
K983895
Beckman Coulter, Inc.
Immunology · 22d
Cleared Oct 16, 1998
TINAQUANT B 2-MICROGLOBULIN ASSAY
K980724
Boehringer Mannheim Corp.
Immunology · 234d
Cleared Nov 20, 1997
IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT
K973813
Beckman Instruments, Inc.
Immunology · 44d
Cleared May 29, 1997
QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA(
K964767
R&D Systems, Inc.
Immunology · 183d
Cleared May 29, 1997
B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K964791
Bayer Corp.
Immunology · 181d
Cleared Oct 03, 1996
N LATEX B2-MICROGLOBULIN REAGENT
K955596
Behring Diagnostics, Inc.
Immunology · 300d
Cleared Jan 30, 1996
HUMAN BETA-2 MICROGLOBULIN ENHANCED RADIAL IMMUNODIFFUSION KIT
K946068
The Binding Site, Ltd.
Immunology · 433d
Cleared Jan 30, 1996
HUMAN BETA-2 MICROGLOBULIN ENHANCED NEPHELOMETRIC KIT
K946069
The Binding Site, Ltd.
Immunology · 433d
Cleared Jan 30, 1996
HUMAN BETA-2 MICROGLOBULIN TURBINDIMETRIC KIT
K946070
The Binding Site, Ltd.
Immunology · 433d
Cleared Jun 20, 1995
AURAFLEX B2-MICROGLOBULIN
K944846
Organon Teknika Corp.
Immunology · 263d
Cleared May 15, 1995
IL TEST BETA-2MICROGLOBULIN
K943686
Instrumentation Laboratory CO
Immunology · 290d
Cleared Apr 21, 1994
BECKMAN BETA-2-MICROGLOBULIN (B2M)
K940353
Beckman Instruments, Inc.
Immunology · 86d
Cleared Sep 24, 1993
IMMULITE BETA-2-MICROGLOBULIN
K931702
Diagnostic Products Corp.
Immunology · 171d
Cleared Sep 23, 1992
COULTER BETA-2 MICROGLOBULIN IMMUNOASSAY
K923421
Coulter Corp.
Immunology · 72d
Cleared May 28, 1992
SYN ELISA BETA 2 MICROGLOBULIN TEST KIT
K920132
Elias U.S.A., Inc.
Immunology · 136d

About Product Code JZG - Regulatory Context