Company ยท NL
Eurotrol B.V.
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2019. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 15, 2019 | K192842 | HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High Eurotrol B.V., NL | GGM |
| Feb 1, 2019 | K182744 | HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High Eurotrol B.V., NL | GGM |
| Apr 22, 2016 | K152553 | CueSee Hypoxic Eurotrol B.V., NL | JJS |
| Jul 26, 2013 | K131595 | EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM Eurotrol B.V., NL | JJY |
| May 10, 2013 | K121467 | EUROTROL HEMATOCRIT CONTROL Eurotrol B.V., NL | GLK |
| Jun 22, 2012 | K121468 | EUROTROL GAS-ISE METABOLITES Eurotrol B.V., NL | JJY |
| Mar 24, 2006 | K060215 | ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002 Eurotrol B.V. | JJX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2018 | EUROTROL INC HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture.
Catalogue number: 171.003.002
Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verifica Terminated |
GGM | K964052 |
| Oct 18, 2018 | EUROTROL INC HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture
Catalogue number: 171.002.002
Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verificat Terminated |
GGM | K964052 |