510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K790282Substantially Equivalent

Eldoncard

Nordisk Infuser System, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K790282 is the FDA 510(k) clearance record for ELDONCARD, a class II device, cleared for Nordisk Infuser System on under FDA product code KSZ (System, Test, Automated Blood Grouping And Antibody). FDA records list 2 510(k) clearances for Nordisk Infuser System, from to . As of , FDA records show no recalls naming K790282.

Clearance record

Decision date
Received
(80 days to decision)
Product code
KSZ System, Test, Automated Blood Grouping And Antibody
Regulation
21 CFR 864.9175
Device class
Class II
Review panel
Hematology
Applicant
Nordisk Infuser System 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KSZ

Trailing 12 months

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

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