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FDA 510(k)

MEDICA EASYQC HEMATOCRIT CONTROL

K-Number: K021924 · 2002-06-24

ApplicantBionostics, Inc.
Decision Date2002-06-24
Product CodeGLK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MEDICA EASYQC HEMATOCRIT CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Bionostics, Inc.. It received FDA 510(k) clearance on 2002-06-24 under 510(k) number K021924. 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 MEDICA EASYQC HEMATOCRIT CONTROL?

MEDICA EASYQC HEMATOCRIT CONTROL is a medical device that received FDA 510(k) clearance on 2002-06-24. The listed applicant is Bionostics, Inc.. The 510(k) number is K021924.

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

MEDICA EASYQC HEMATOCRIT CONTROL received FDA 510(k) clearance on 2002-06-24, under 510(k) number K021924.

Who is the listed applicant for MEDICA EASYQC HEMATOCRIT CONTROL?

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

What is the FDA product code for MEDICA EASYQC HEMATOCRIT CONTROL?

The FDA product code for MEDICA EASYQC 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.

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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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