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

Elizabethtown, KY, US

EUROTROL B.V. appears in FDA device records in Elizabethtown, KY. FDA records list 7 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
7
PMA records
0
Recall records
2
Registered establishments
2

510(k) clearance history

FDA records hold 7 510(k) clearances for Eurotrol B.V. between 2006 and 2019. The busiest year on record is 2013, with 2. The most recent is 2019, with 2.

Clearances by year, as a table
510(k) clearance decisions for Eurotrol B.V., by decision year
YearClearances
20061
20121
20132
20161
20192
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K192842HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo HighGGMSubstantially Equivalent
K182744HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - HighGGMSubstantially Equivalent
K152553CueSee HypoxicJJSSubstantially Equivalent
K131595EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVMJJYSubstantially Equivalent
K121467EUROTROL HEMATOCRIT CONTROLGLKSubstantially Equivalent
K121468EUROTROL GAS-ISE METABOLITESJJYSubstantially Equivalent
K060215ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002JJXSubstantially Equivalent

Registered establishments

FDA registered establishments for Eurotrol B.V., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96815183005695774EUROTROL B.V.KEPLERLAAN 20, EDE Gelderland 6716 BS NL2026
30058377643005837764EUROTROL, INC.850 N Black Branch Rd, Elizabethtown, KY 42701 US2026No device listings on this registration

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0515-2019HemoTrol 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 verification of the linearity of the HemoCue Hb 201 systems.Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned valuesClass IITerminated
Z-0514-2019HemoTrol 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 verification of the linearity of the HemoCue Hb 201 systemsIncorrect measurement results caused by microbial contamination of the product, results in values lower than assigned valuesClass IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain