Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JZG — Predicate Candidate Screening
53 FDA 510(k) clearances under this product code; the 50 most recent screened below.
86 daysmedian FDA review time
290 days90th percentile
53clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161297 | Beta-2-Microglobulin | Beckman Coulter Ireland, Inc. | 2016-06-07 | 29 | 0 |
| K122066 | HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS | The Binding Site Group , Ltd. | 2012-08-30 | 45 | 0 |
| K110874 | ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBUL | Siemens Healthcare Diagnostics, Inc. | 2012-01-20 | 297 | 0 |
| K083289 | HUMAN BETA-2 MICROGLOBULIN KIT | The Binding Site, Ltd. | 2009-05-06 | 180 | 0 |
| K083463 | DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEI | Siemens Healthcare Diagnostics | 2009-03-13 | 109 | 2 |
| K072078 | QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 | Biokit, S.A. | 2007-12-19 | 142 | 0 |
| K063272 | DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALI | Dade Behring, Inc. | 2007-01-26 | 88 | 0 |
| K050613 | QUANTIA BETA-2 MICROGLOBULIN | Biokit, S.A. | 2005-08-16 | 159 | 0 |
| K032692 | DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 | Dako A/S | 2004-01-22 | 142 | 0 |
| K014270 | MININEPH HUMAN B2-MICROGLOBULIN KIT | The Binding Site, Ltd. | 2002-08-15 | 231 | 0 |
| K002731 | N LATEX B2-MICROGLOBULIN | Dade Behring, Inc. | 2000-11-20 | 80 | 0 |
| K001022 | BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, M | Biocheck, Inc. | 2000-09-26 | 180 | 0 |
| K993711 | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITR | Bayer Corp. | 1999-12-16 | 43 | 0 |
| K991136 | B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM | Olympus America, Inc. | 1999-05-11 | 36 | 0 |
| K983895 | IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT | Beckman Coulter, Inc. | 1998-11-25 | 22 | 0 |
| K980724 | TINAQUANT B 2-MICROGLOBULIN ASSAY | Boehringer Mannheim Corp. | 1998-10-16 | 234 | 0 |
| K973813 | IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT | Beckman Instruments, Inc. | 1997-11-20 | 44 | 0 |
| K964767 | QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA( | R&D Systems, Inc. | 1997-05-29 | 183 | 0 |
| K964791 | B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN | Bayer Corp. | 1997-05-29 | 181 | 0 |
| K955596 | N LATEX B2-MICROGLOBULIN REAGENT | Behring Diagnostics, Inc. | 1996-10-03 | 300 | 0 |
| K946069 | HUMAN BETA-2 MICROGLOBULIN ENHANCED NEPHELOMETRIC KIT | The Binding Site, Ltd. | 1996-01-30 | 433 | 0 |
| K946070 | HUMAN BETA-2 MICROGLOBULIN TURBINDIMETRIC KIT | The Binding Site, Ltd. | 1996-01-30 | 433 | 0 |
| K946068 | HUMAN BETA-2 MICROGLOBULIN ENHANCED RADIAL IMMUNODIFFUSION K | The Binding Site, Ltd. | 1996-01-30 | 433 | 0 |
| K944846 | AURAFLEX B2-MICROGLOBULIN | Organon Teknika Corp. | 1995-06-20 | 263 | 0 |
| K943686 | IL TEST BETA-2MICROGLOBULIN | Instrumentation Laboratory CO | 1995-05-15 | 290 | 0 |
| K946048 | LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2 | Clinical Controls, Inc. | 1995-02-10 | 60 | 0 |
| K940353 | BECKMAN BETA-2-MICROGLOBULIN (B2M) | Beckman Instruments, Inc. | 1994-04-21 | 86 | 0 |
| K931702 | IMMULITE BETA-2-MICROGLOBULIN | Diagnostic Products Corp. | 1993-09-24 | 171 | 0 |
| K933648 | ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PAC | Dupont Medical Products | 1993-09-24 | 59 | 0 |
| K923421 | COULTER BETA-2 MICROGLOBULIN IMMUNOASSAY | Coulter Corp. | 1992-09-23 | 72 | 0 |
| K920132 | SYN ELISA BETA 2 MICROGLOBULIN TEST KIT | Elias U.S.A., Inc. | 1992-05-28 | 136 | 0 |
| K915508 | DSL ACTIVE BETA2-MICROGLOBULIN (DSL 6500) | Diagnostic Systems Laboratories, Inc. | 1992-03-17 | 99 | 0 |
| K920300 | B2-MICROGLOBULIN RADIOIMMUNOASSAY | Nichols Institute | 1992-03-17 | 55 | 0 |
| K914225 | ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1991-11-22 | 63 | 0 |
| K913131 | HUMAN BETA-2 MICROGLOBIN EN-RID KIT | The Binding Site, Ltd. | 1991-11-07 | 114 | 0 |
| K911881 | DSL BETA 2 MICROGLOBULIN (DSL 6200) | Diagnostic Systems Laboratories, Inc. | 1991-09-10 | 134 | 0 |
| K912173 | DSL BETA 2 MICROGLOBULIN (DSL 6100) | Diagnostic Systems Laboratories, Inc. | 1991-08-13 | 89 | 0 |
| K912940 | COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA | Diagnostic Products Corp. | 1991-07-24 | 19 | 0 |
| K904254 | NA ALPHA 1 MICROGLOBULIN KIT | Behring Diagnostics, Inc. | 1991-04-05 | 203 | 0 |
| K910052 | MILENIA BETA-2 MICROGLOBULIN | Diagnostic Products Corp. | 1991-03-06 | 58 | 0 |
| K903215 | LABMASTER BETA-2-MICROGLOBULIN ELISA TEST KIT TM | Bioproducts For Science, Inc. | 1990-09-25 | 64 | 0 |
| K903578 | PHARMACIA DELFIA SYSTEM B2-MICRO | Pharmacia, Inc. | 1990-08-17 | 9 | 0 |
| K901333 | BETA-2 MICROGLOBULIN EIA | Serex, Inc. | 1990-04-02 | 13 | 0 |
| K900440 | AIA-PACK BMG | Tosoh Medics, Inc. | 1990-02-26 | 28 | 0 |
| K900449 | PHARMACIA B2 MICRO EIA | Pharmacia, Inc. | 1990-02-05 | 6 | 0 |
| K895496 | BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA | Incstar Corp. | 1989-10-17 | 69 | 0 |
| K890694 | BETA-2 MICROGLOBULIN EIA | Serex, Inc. | 1989-03-16 | 34 | 0 |
| K890421 | IMX B2-MICROGLOBULIN | Abbott Laboratories | 1989-03-09 | 42 | 0 |
| K880719 | PHARMACIA B2-MICRO RIA | Pharmacia, Inc. | 1988-04-21 | 58 | 0 |
| K864130 | ABBOTT B2-MICROGLOBULIN RIA | Abbott Laboratories | 1986-11-12 | 22 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda