510(k) K161297
- Device
- Beta-2-Microglobulin
- Applicant
- Beckman Coulter Ireland Inc.
- 510(k) number
- K161297
- Product code
- JZG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-06-07
- Date received
- 2016-05-09
- Regulation
- 866.5630
- Classification name
- System, Test, Beta-2-microglobulin Immunological
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Eimear Carr
- Address
- Lismeehan O' Callaghan'S, Mills Co. Clare IE
FDA Registration Numbers#
- 2084025
- 3006198300
- 3002800697
- 3003795116
- 3009189893
- 9610099
- 9680746
- 2050012
- 9610806
- 2245285
- 3005333358
- 3003741796
- 9610529
- 3022178699
- 2432235
- 1832216
- 9612316
- 1036362
- 3003423869
- 8031673
- 3014607865
- 3013059683
- 9610746
- 3004493545
- 3005984081
- 2050010
- 3012471076
- 3003871639
- 3014325803
- 3005529799
- 9610126
- 3017379203
- 3002806944
- 9614373
Source Documents#
Other 510(k) Records For Product Code JZG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K122066 | HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS | The Binding Site Group , Ltd. | 2012-08-30 |
| K110874 | ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | 2012-01-20 |
| K083289 | HUMAN BETA-2 MICROGLOBULIN KIT | The Binding Site, Ltd. | 2009-05-06 |
| K083463 | DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M | Siemens Healthcare Diagnostics | 2009-03-13 |
| K072078 | QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 | Biokit, S.A. | 2007-12-19 |
| K063272 | DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH | Dade Behring, Inc. | 2007-01-26 |
| K050613 | QUANTIA BETA-2 MICROGLOBULIN | Biokit, S.A. | 2005-08-16 |
| K032692 | DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 | Dako A/S | 2004-01-22 |
| K014270 | MININEPH HUMAN B2-MICROGLOBULIN KIT | The Binding Site, Ltd. | 2002-08-15 |
| K002731 | N LATEX B2-MICROGLOBULIN | Dade Behring, Inc. | 2000-11-20 |
| K001022 | BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 | Biocheck, Inc. | 2000-09-26 |
| K993711 | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS) | Bayer Corp. | 1999-12-16 |
| K991136 | B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM | Olympus America, Inc. | 1999-05-11 |
| K983895 | IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT | Beckman Coulter, Inc. | 1998-11-25 |
| K980724 | TINAQUANT B 2-MICROGLOBULIN ASSAY | Boehringer Mannheim Corp. | 1998-10-16 |
Legacy Summary#
summary
FDA Review#
Decision Summary