510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K872539Substantially Equivalent

Eurogenetics Crp Elisa

Eurogenetics, North Caldwell NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K872539 is the FDA 510(k) clearance record for EUROGENETICS CRP ELISA, a class II device, cleared for Eurogenetics on under FDA product code DCN (System, Test, C-Reactive Protein). FDA records list one 510(k) clearance for Eurogenetics. As of , FDA records show no recalls naming K872539.

Clearance record

Decision date
Received
(113 days to decision)
Product code
DCN System, Test, C-Reactive Protein
Regulation
21 CFR 866.5270
Device class
Class II
Review panel
Immunology
Applicant
Eurogenetics 583 Mountain Ave., North Caldwell NJ
Third party review
No

Clearances, product code DCN

Trailing 12 months

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

FDA records show no clearances under product code DCN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DCN, 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