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FDA 510(k)

MSI-HCT

K-Number: K924926 · 1993-01-07

ApplicantMedical Specialties, Inc.
Decision Date1993-01-07
Product CodeGLK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MSI-HCT is the device name listed in this FDA 510(k) record. The listed applicant is Medical Specialties, Inc.. It received FDA 510(k) clearance on 1993-01-07 under 510(k) number K924926. 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 MSI-HCT?

MSI-HCT is a medical device that received FDA 510(k) clearance on 1993-01-07. The listed applicant is Medical Specialties, Inc.. The 510(k) number is K924926.

When did MSI-HCT receive FDA 510(k) clearance?

MSI-HCT received FDA 510(k) clearance on 1993-01-07, under 510(k) number K924926.

Who is the listed applicant for MSI-HCT?

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

What is the FDA product code for MSI-HCT?

The FDA product code for MSI-HCT is GLK.

Other records listing Medical Specialties, Inc. 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.

K946201STAND, INFUSIONK931947CHECKPOINTK926095REFRACTROL-SPK896566MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVEK883851MSI-CAL 8K883703MSI-CAL 7

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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.K964452HEMATACHEKRichmond Diagnostics, Inc.K961807CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4Ciba Corning Diagnostics Corp.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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