510(k) K190298
- Device
- DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12
- Applicant
- Beckman Coulter Biomedical GmbH
- 510(k) number
- K190298
- Product code
- CDD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-10-04
- Date received
- 2019-02-11
- Regulation
- 862.1810
- Classification name
- Radioassay, Vitamin B12
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Amanda Brown
- Address
- Sauerbruchstr. 50 Munich DE 81377 81377
FDA Registration Numbers#
- 3015969360
- 3005094123
- 3006198300
- 3006677029
- 9680746
- 3005333358
- 2432235
- 3022178699
- 3002809144
- 2182595
- 9612316
- 2020726
- 3009518015
- 1036362
- 8032314
- 2517506
- 2122870
- 8031673
- 2032682
- 3011989923
- 3033967997
- 8020888
- 1219913
- 3005529799
- 3007111389
- 9610126
- 1319681
- 3002806944
- 3005655287
- 2032839
- 3004192065
Source Documents#
Other 510(k) Records For Product Code CDD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233541 | ARCHITECT Active-B12 (Holotranscobalamin) | Axis-Shield Diagnostics, Ltd. | 2024-07-31 |
| K223289 | Access Vitamin B12 | Beckman Coulter, Inc. | 2022-12-23 |
| K192064 | LIAISON Vitamin B12 | DiaSorin, Inc. | 2019-10-02 |
| K172133 | ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay | Axis-Shield Diagnostics, Ltd. | 2017-10-27 |
| K161721 | Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set | Diazyme Laboratories | 2016-09-20 |
| K160757 | ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) | Axis-Shield Diagnostics Limited | 2016-07-26 |
| K151786 | Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet | Roche Diagnostics | 2015-09-24 |
| K140496 | Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents | Beckman Coulter, Inc. | 2014-09-16 |
| K133512 | LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL) | Siemens Healthcare Diagnostics | 2014-01-02 |
| K121946 | AXIS-SHIELD ACVTIVE-B12 | Axis-Shield Diagnostics, Ltd. | 2013-03-22 |
| K121994 | DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | 2012-11-30 |
| K111260 | A/C ENZYMATIC VITAMIN B6 ASSAY | Anticancer, Inc. | 2012-07-26 |
| K121314 | ARCHITECT B12 | Abbott Laboratories | 2012-05-17 |
| K112443 | ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) | Axis-Shield Diagnostics, Ltd. | 2011-12-19 |
| K110579 | ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS | Abbott Laboratories | 2011-10-06 |
Legacy Summary#
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FDA Review#
Decision Summary