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FDA 510(k)

EUROTROL HEMATOCRIT CONTROL

K-Number: K121467 · 2013-05-10

ApplicantEurotrol B.V.
Decision Date2013-05-10
Product CodeGLK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

EUROTROL HEMATOCRIT CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Eurotrol B.V.. It received FDA 510(k) clearance on 2013-05-10 under 510(k) number K121467. The device is classified under product code GLK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUROTROL HEMATOCRIT CONTROL?

EUROTROL HEMATOCRIT CONTROL is a medical device that received FDA 510(k) clearance on 2013-05-10. The listed applicant is Eurotrol B.V.. The 510(k) number is K121467.

When did EUROTROL HEMATOCRIT CONTROL receive FDA 510(k) clearance?

EUROTROL HEMATOCRIT CONTROL received FDA 510(k) clearance on 2013-05-10, under 510(k) number K121467.

Who is the listed applicant for EUROTROL HEMATOCRIT CONTROL?

The FDA 510(k) record lists Eurotrol B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EUROTROL HEMATOCRIT CONTROL?

The FDA product code for EUROTROL HEMATOCRIT CONTROL is GLK.

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Other records listing Eurotrol B.V. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192842HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo HighK182744HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - HighK152553CueSee HypoxicK131595EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVMK121468EUROTROL GAS-ISE METABOLITESK060215ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002

View all 7 devices →

Related Devices (Code: GLK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K021924MEDICA EASYQC HEMATOCRIT CONTROLBionostics, Inc.K020618AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROLAalto Scientific, Ltd.K964452HEMATACHEKRichmond Diagnostics, Inc.K961807CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4Ciba Corning Diagnostics Corp.K924926MSI-HCTMedical Specialties, Inc.K893562A.QC HCT LEVEL 1 AND 2Johnson & Johnson Professionals, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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