FDA.reportPublic FDA data

510(k) K223289

Device
Access Vitamin B12
Applicant
Beckman Coulter, Inc.
510(k) number
K223289
Product code
CDD
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-23
Date received
2022-10-25
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
Kuljeet Kaur
Address
1000 Lake Hazeltine Dr. Chaska MN US 55318 55318

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CDD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K233541ARCHITECT Active-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd.2024-07-31
K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12Beckman Coulter Biomedical GmbH2019-10-04
K192064LIAISON Vitamin B12DiaSorin, Inc.2019-10-02
K172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayAxis-Shield Diagnostics, Ltd.2017-10-27
K161721Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls SetDiazyme Laboratories2016-09-20
K160757ADVIA 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 Limited2016-07-26
K151786Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSetRoche Diagnostics2015-09-24
K140496Access 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 ReagentsBeckman Coulter, Inc.2014-09-16
K133512LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)Siemens Healthcare Diagnostics2014-01-02
K121946AXIS-SHIELD ACVTIVE-B12Axis-Shield Diagnostics, Ltd.2013-03-22
K121994DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATORSiemens Healthcare Diagnostics, Inc.2012-11-30
K111260A/C ENZYMATIC VITAMIN B6 ASSAYAnticancer, Inc.2012-07-26
K121314ARCHITECT B12Abbott Laboratories2012-05-17
K112443ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)Axis-Shield Diagnostics, Ltd.2011-12-19
K110579ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLSAbbott Laboratories2011-10-06