510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190298Substantially Equivalent

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

Beckman Coulter Biomedical GmbH, Munich, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190298 is the FDA 510(k) clearance record for DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12, a class II device, cleared for Beckman Coulter Biomedical GmbH on under FDA product code CDD (Radioassay, Vitamin B12). FDA records list one 510(k) clearance for Beckman Coulter Biomedical GmbH. As of , FDA records show 4 recalls naming K190298.

Clearance record

Decision date
Received
(235 days to decision)
Product code
CDD Radioassay, Vitamin B12
Regulation
21 CFR 862.1810
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Beckman Coulter Biomedical GmbH Sauerbruchstr. 50, Munich, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CDD

Trailing 12 months

FDA records hold no clearances under product code CDD in the trailing twelve months.

FDA records show no clearances under product code CDD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CDD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260