JZG — System, Test, Beta-2-Microglobulin Immunological Class II
FDA product code JZG covers "System, Test, Beta-2-Microglobulin Immunological", a Class II medical device regulated under 21 CFR 866.5630. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
| K964791 | bayer | B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SY | May 29, 1997 |
| K964767 | r and d systems | QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA( | May 29, 1997 |
| K955596 | behring diagnostics | N LATEX B2-MICROGLOBULIN REAGENT | October 3, 1996 |