Cleared Traditional

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

K190298 · Beckman Coulter Biomedical GmbH · Chemistry

Oct 2019

Decision

235d

Days

Class 2

Risk

About This 510(k) Submission

K190298 is an FDA 510(k) clearance for the DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12, a Radioassay, Vitamin B12 (Class II — Special Controls, product code CDD), submitted by Beckman Coulter Biomedical GmbH (Munich, DE). The FDA issued a Cleared decision on October 4, 2019, 235 days after receiving the submission on February 11, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1810.

Submission Details

510(k) Number	K190298 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 11, 2019
Decision Date	October 04, 2019
Days to Decision	235 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF