510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K051968Substantially Equivalent

Abl8x7 Flex

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

K051968 is the FDA 510(k) clearance record for ABL8X7 FLEX, a class II device, cleared for Radiometer Medical Aps on under FDA product code CGL (Electrode, Ion Based, Enzymatic, Creatinine). FDA records list 30 510(k) clearances for Radiometer Medical Aps, from to . As of , FDA records show 4 recalls naming K051968.

Clearance record

Decision date
Received
(453 days to decision)
Product code
CGL Electrode, Ion Based, Enzymatic, Creatinine
Regulation
21 CFR 862.1225
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Radiometer Medical Aps Akandevej 21 Dk-2700, Bronshoj, DK
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CGL

Trailing 12 months
1 clearance under product code CGL in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CGL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260