510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K150226Substantially Equivalent

Hematocrit and Metabolite QUALICHECK

Radiometer Medical ApS, Bronshoj, DK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150226 is the FDA 510(k) clearance record for Hematocrit and Metabolite QUALICHECK, a class I device, cleared for Radiometer Medical Aps on under FDA product code JJS (Controls For Blood-Gases, (Assayed And Unassayed)). FDA records list 30 510(k) clearances for Radiometer Medical Aps, from to . As of , FDA records show no recalls naming K150226.

Clearance record

Decision date
Received
(100 days to decision)
Product code
JJS Controls For Blood-Gases, (Assayed And Unassayed)
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Radiometer Medical Aps Akandevej 21, Bronshoj, DK
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JJS

Trailing 12 months

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

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