510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192842Substantially Equivalent

HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High

Eurotrol B.V., Ede, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192842 is the FDA 510(k) clearance record for HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High, a class II device, cleared for Eurotrol B.V. on under FDA product code GGM (Control, Hemoglobin). FDA records list 7 510(k) clearances for Eurotrol B.V., from to . As of , FDA records show no recalls naming K192842.

Clearance record

Decision date
Received
(43 days to decision)
Product code
GGM Control, Hemoglobin
Regulation
21 CFR 864.8625
Device class
Class II
Review panel
Hematology
Applicant
Eurotrol B.V. Keplerlaan 20, Ede, NL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GGM

Trailing 12 months

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

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