510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112161Substantially Equivalent

Aqt90 Flex Analyzer, Aqt90 Flex Myoglobin Test Kit, Aqt90 Flex Lqc Multi-Check, Lvls 1-3, Aqt90 Flex Myo Cal Cartridge..

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

K112161 is the FDA 510(k) clearance record for AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE.., a class I device, cleared for Radiometer Medical Aps on under FDA product code KHO (Fluorometer, For Clinical Use). FDA records list 30 510(k) clearances for Radiometer Medical Aps, from to . As of , FDA records show no recalls naming K112161.

Clearance record

Decision date
Received
(177 days to decision)
Product code
KHO Fluorometer, For Clinical Use
Regulation
21 CFR 862.2560
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Radiometer Medical Aps Aakandevej 21, Broenshoej, DK
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KHO

Trailing 12 months

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

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