JZG — System, Test, Beta-2-Microglobulin Immunological Class II
FDA Device Classification
Classification Details
- Product Code
- JZG
- Device Class
- Class II
- Regulation Number
- 866.5630
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K161297 | beckman coulter ireland | Beta-2-Microglobulin | June 7, 2016 |
| K122066 | binding site group | HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS | August 30, 2012 |
| K110874 | siemens healthcare diagnostics | ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR | January 20, 2012 |
| K083289 | binding site | HUMAN BETA-2 MICROGLOBULIN KIT | May 6, 2009 |
| K083463 | siemens healthcare diagnostics | DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIME | March 13, 2009 |
| K072078 | biokit | QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 | December 19, 2007 |
| K063272 | dade behring | DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDI | January 26, 2007 |
| K050613 | biokit | QUANTIA BETA-2 MICROGLOBULIN | August 16, 2005 |
| K032692 | dako | DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 | January 22, 2004 |
| K014270 | binding site | MININEPH HUMAN B2-MICROGLOBULIN KIT | August 15, 2002 |
| K002731 | dade behring | N LATEX B2-MICROGLOBULIN | November 20, 2000 |
| K001022 | biocheck | BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 | September 26, 2000 |
| K993711 | bayer | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM | December 16, 1999 |
| K991136 | olympus america | B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM | May 11, 1999 |
| K983895 | beckman coulter | IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT | November 25, 1998 |
| K980724 | boehringer mannheim | TINAQUANT B 2-MICROGLOBULIN ASSAY | October 16, 1998 |
| K973813 | beckman instruments | IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT | November 20, 1997 |
| K964767 | r and d systems | QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA( | May 29, 1997 |
| K964791 | bayer | B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SY | May 29, 1997 |
| K955596 | behring diagnostics | N LATEX B2-MICROGLOBULIN REAGENT | October 3, 1996 |