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FDA 510(k)

AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL

K-Number: K020618 · 2002-05-14

ApplicantAalto Scientific, Ltd.
Decision Date2002-05-14
Product CodeGLK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Aalto Scientific, Ltd.. It received FDA 510(k) clearance on 2002-05-14 under 510(k) number K020618. 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 AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL?

AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL is a medical device that received FDA 510(k) clearance on 2002-05-14. The listed applicant is Aalto Scientific, Ltd.. The 510(k) number is K020618.

When did AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL receive FDA 510(k) clearance?

AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL received FDA 510(k) clearance on 2002-05-14, under 510(k) number K020618.

Who is the listed applicant for AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL?

The FDA 510(k) record lists Aalto Scientific, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL?

The FDA product code for AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL is GLK.

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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.

K121467EUROTROL HEMATOCRIT CONTROLEurotrol B.V.K021924MEDICA EASYQC HEMATOCRIT CONTROLBionostics, Inc.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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