Last synced on 30 September 2022 at 11:05 pm

DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190298
510(k) Type
Traditional
Applicant
Beckman Coulter Biomedical GmbH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
10/4/2019
Days to Decision
235 days
Submission Type
Summary

DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190298
510(k) Type
Traditional
Applicant
Beckman Coulter Biomedical GmbH
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
10/4/2019
Days to Decision
235 days
Submission Type
Summary