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FDA 510(k)

HEMATACHEK

K-Number: K964452 · 1997-02-20

ApplicantRichmond Diagnostics, Inc.
Decision Date1997-02-20
Product CodeGLK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMATACHEK is the device name listed in this FDA 510(k) record. The listed applicant is Richmond Diagnostics, Inc.. It received FDA 510(k) clearance on 1997-02-20 under 510(k) number K964452. 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 HEMATACHEK?

HEMATACHEK is a medical device that received FDA 510(k) clearance on 1997-02-20. The listed applicant is Richmond Diagnostics, Inc.. The 510(k) number is K964452.

When did HEMATACHEK receive FDA 510(k) clearance?

HEMATACHEK received FDA 510(k) clearance on 1997-02-20, under 510(k) number K964452.

Who is the listed applicant for HEMATACHEK?

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

What is the FDA product code for HEMATACHEK?

The FDA product code for HEMATACHEK 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.K020618AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROLAalto Scientific, Ltd.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

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

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