FDA 510(k) Applications for Medical Device Product Code "JZG"
(System, Test, Beta-2-Microglobulin Immunological)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K993711 | BAYER CORP. | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS) | 12/16/1999 |
| K964791 | BAYER CORP. | B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | 05/29/1997 |
| K161297 | Beckman Coulter Ireland Inc. | Beta-2-Microglobulin | 06/07/2016 |
| K983895 | BECKMAN COULTER, INC. | IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT | 11/25/1998 |
| K973813 | BECKMAN INSTRUMENTS, INC. | IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT | 11/20/1997 |
| K955596 | BEHRING DIAGNOSTICS, INC. | N LATEX B2-MICROGLOBULIN REAGENT | 10/03/1996 |
| K001022 | BIOCHECK, INC. | BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 | 09/26/2000 |
| K050613 | BIOKIT S.A. | QUANTIA BETA-2 MICROGLOBULIN | 08/16/2005 |
| K072078 | BIOKIT S.A. | QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 | 12/19/2007 |
| K980724 | BOEHRINGER MANNHEIM CORP. | TINAQUANT B 2-MICROGLOBULIN ASSAY | 10/16/1998 |
| K063272 | DADE BEHRING, INC. | DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH | 01/26/2007 |
| K002731 | DADE BEHRING, INC. | N LATEX B2-MICROGLOBULIN | 11/20/2000 |
| K032692 | DAKO A/S | DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 | 01/22/2004 |
| K991136 | OLYMPUS AMERICA, INC. | B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM | 05/11/1999 |
| K964767 | R & D SYSTEMS, INC. | QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA( | 05/29/1997 |
| K083463 | SIEMENS HEALTHCARE DIAGNOSTICS | DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M | 03/13/2009 |
| K110874 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. | ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR | 01/20/2012 |
| K122066 | THE BINDING SITE GROUP LTD | HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS | 08/30/2012 |
| K946069 | THE BINDING SITE, LTD. | HUMAN BETA-2 MICROGLOBULIN ENHANCED NEPHELOMETRIC KIT | 01/30/1996 |
| K946068 | THE BINDING SITE, LTD. | HUMAN BETA-2 MICROGLOBULIN ENHANCED RADIAL IMMUNODIFFUSION KIT | 01/30/1996 |
| K083289 | THE BINDING SITE, LTD. | HUMAN BETA-2 MICROGLOBULIN KIT | 05/06/2009 |
| K946070 | THE BINDING SITE, LTD. | HUMAN BETA-2 MICROGLOBULIN TURBINDIMETRIC KIT | 01/30/1996 |
| K014270 | THE BINDING SITE, LTD. | MININEPH HUMAN B2-MICROGLOBULIN KIT | 08/15/2002 |
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