FDA Product Code
FDA Product Code JZG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5630
510(k) Clearances — 53 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K161297 | Beta-2-Microglobulin | Beckman Coulter Ireland, Inc. | 2016-06-07 | Special | PDF ↗ |
| K122066 | HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS | The Binding Site Group , Ltd. | 2012-08-30 | Special | PDF ↗ |
| K110874 | ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | 2012-01-20 | Traditional | PDF ↗ |
| K083289 | HUMAN BETA-2 MICROGLOBULIN KIT | The Binding Site, Ltd. | 2009-05-06 | Traditional | PDF ↗ |
| K083463 | DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M | Siemens Healthcare Diagnostics | 2009-03-13 | Traditional | PDF ↗ |
| K072078 | QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 | Biokit, S.A. | 2007-12-19 | Traditional | PDF ↗ |
| K063272 | DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH | Dade Behring, Inc. | 2007-01-26 | Traditional | PDF ↗ |
| K050613 | QUANTIA BETA-2 MICROGLOBULIN | Biokit, S.A. | 2005-08-16 | Traditional | PDF ↗ |
| K032692 | DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 | Dako A/S | 2004-01-22 | Traditional | PDF ↗ |
| K014270 | MININEPH HUMAN B2-MICROGLOBULIN KIT | The Binding Site, Ltd. | 2002-08-15 | Traditional | PDF ↗ |
| K002731 | N LATEX B2-MICROGLOBULIN | Dade Behring, Inc. | 2000-11-20 | Traditional | PDF ↗ |
| K001022 | BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 | Biocheck, Inc. | 2000-09-26 | Traditional | PDF ↗ |
| K993711 | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS) | Bayer Corp. | 1999-12-16 | Traditional | PDF ↗ |
| K991136 | B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM | Olympus America, Inc. | 1999-05-11 | Traditional | PDF ↗ |
| K983895 | IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT | Beckman Coulter, Inc. | 1998-11-25 | Traditional | PDF ↗ |
| K980724 | TINAQUANT B 2-MICROGLOBULIN ASSAY | Boehringer Mannheim Corp. | 1998-10-16 | Traditional | PDF ↗ |
| K973813 | IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT | Beckman Instruments, Inc. | 1997-11-20 | Traditional | PDF ↗ |
| K964767 | QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA( | R&D Systems, Inc. | 1997-05-29 | Traditional | PDF ↗ |
| K964791 | B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | Bayer Corp. | 1997-05-29 | Traditional | PDF ↗ |
| K955596 | N LATEX B2-MICROGLOBULIN REAGENT | Behring Diagnostics, Inc. | 1996-10-03 | Traditional | PDF ↗ |
| K946070 | HUMAN BETA-2 MICROGLOBULIN TURBINDIMETRIC KIT | The Binding Site, Ltd. | 1996-01-30 | Traditional | PDF ↗ |
| K946069 | HUMAN BETA-2 MICROGLOBULIN ENHANCED NEPHELOMETRIC KIT | The Binding Site, Ltd. | 1996-01-30 | Traditional | PDF ↗ |
| K946068 | HUMAN BETA-2 MICROGLOBULIN ENHANCED RADIAL IMMUNODIFFUSION KIT | The Binding Site, Ltd. | 1996-01-30 | Traditional | PDF ↗ |
| K944846 | AURAFLEX B2-MICROGLOBULIN | Organon Teknika Corp. | 1995-06-20 | Traditional | PDF ↗ |
| K943686 | IL TEST BETA-2MICROGLOBULIN | Instrumentation Laboratory CO | 1995-05-15 | Traditional | PDF ↗ |
| K946048 | LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2 | Clinical Controls, Inc. | 1995-02-10 | Traditional | PDF ↗ |
| K940353 | BECKMAN BETA-2-MICROGLOBULIN (B2M) | Beckman Instruments, Inc. | 1994-04-21 | Traditional | PDF ↗ |
| K931702 | IMMULITE BETA-2-MICROGLOBULIN | Diagnostic Products Corp. | 1993-09-24 | Traditional | PDF ↗ |
| K933648 | ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK | Dupont Medical Products | 1993-09-24 | Traditional | PDF ↗ |
| K923421 | COULTER BETA-2 MICROGLOBULIN IMMUNOASSAY | Coulter Corp. | 1992-09-23 | Traditional | PDF ↗ |
| K920132 | SYN ELISA BETA 2 MICROGLOBULIN TEST KIT | Elias U.S.A., Inc. | 1992-05-28 | Traditional | PDF ↗ |
| K920300 | B2-MICROGLOBULIN RADIOIMMUNOASSAY | Nichols Institute | 1992-03-17 | Traditional | PDF ↗ |
| K915508 | DSL ACTIVE BETA2-MICROGLOBULIN (DSL 6500) | Diagnostic Systems Laboratories, Inc. | 1992-03-17 | Traditional | PDF ↗ |
| K914225 | ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1991-11-22 | Traditional | PDF ↗ |
| K913131 | HUMAN BETA-2 MICROGLOBIN EN-RID KIT | The Binding Site, Ltd. | 1991-11-07 | Traditional | PDF ↗ |
| K911881 | DSL BETA 2 MICROGLOBULIN (DSL 6200) | Diagnostic Systems Laboratories, Inc. | 1991-09-10 | Traditional | PDF ↗ |
| K912173 | DSL BETA 2 MICROGLOBULIN (DSL 6100) | Diagnostic Systems Laboratories, Inc. | 1991-08-13 | Traditional | PDF ↗ |
| K912940 | COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA | Diagnostic Products Corp. | 1991-07-24 | Traditional | PDF ↗ |
| K904254 | NA ALPHA 1 MICROGLOBULIN KIT | Behring Diagnostics, Inc. | 1991-04-05 | Traditional | PDF ↗ |
| K910052 | MILENIA BETA-2 MICROGLOBULIN | Diagnostic Products Corp. | 1991-03-06 | Traditional | PDF ↗ |
| K903215 | LABMASTER BETA-2-MICROGLOBULIN ELISA TEST KIT TM | Bioproducts For Science, Inc. | 1990-09-25 | Traditional | PDF ↗ |
| K903578 | PHARMACIA DELFIA SYSTEM B2-MICRO | Pharmacia, Inc. | 1990-08-17 | Traditional | PDF ↗ |
| K901333 | BETA-2 MICROGLOBULIN EIA | Serex, Inc. | 1990-04-02 | Traditional | PDF ↗ |
| K900440 | AIA-PACK BMG | Tosoh Medics, Inc. | 1990-02-26 | Traditional | PDF ↗ |
| K900449 | PHARMACIA B2 MICRO EIA | Pharmacia, Inc. | 1990-02-05 | Traditional | PDF ↗ |
| K895496 | BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA | Incstar Corp. | 1989-10-17 | Traditional | PDF ↗ |
| K890694 | BETA-2 MICROGLOBULIN EIA | Serex, Inc. | 1989-03-16 | Traditional | PDF ↗ |
| K890421 | IMX B2-MICROGLOBULIN | Abbott Laboratories | 1989-03-09 | Traditional | PDF ↗ |
| K880719 | PHARMACIA B2-MICRO RIA | Pharmacia, Inc. | 1988-04-21 | Traditional | PDF ↗ |
| K864130 | ABBOTT B2-MICROGLOBULIN RIA | Abbott Laboratories | 1986-11-12 | Traditional | PDF ↗ |
| K844469 | PHARMACIA B2-MICRO EIA | Pharmacia, Inc. | 1985-02-14 | Traditional | PDF ↗ |
| K843967 | ENZYGNOST BETA-2 MICROGLOBULIN TEST | Behring Diagnostics, Inc. | 1984-12-03 | Traditional | PDF ↗ |
| K840601 | B2-MICRO CONTROL | Pharmacia, Inc. | 1984-04-20 | Traditional | PDF ↗ |
Product code JZG · Class II · Immunology. Data: openFDA.