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FDA 510(k)

INRATIO SELF-TEST

K-Number: K021923 · 2002-10-24

ApplicantHemosense, Inc.
Decision Date2002-10-24
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

INRATIO SELF-TEST is the device name listed in this FDA 510(k) record. The listed applicant is Hemosense, Inc.. It received FDA 510(k) clearance on 2002-10-24 under 510(k) number K021923. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INRATIO SELF-TEST?

INRATIO SELF-TEST is a medical device that received FDA 510(k) clearance on 2002-10-24. The listed applicant is Hemosense, Inc.. The 510(k) number is K021923.

When did INRATIO SELF-TEST receive FDA 510(k) clearance?

INRATIO SELF-TEST received FDA 510(k) clearance on 2002-10-24, under 510(k) number K021923.

Who is the listed applicant for INRATIO SELF-TEST?

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

What is the FDA product code for INRATIO SELF-TEST?

The FDA product code for INRATIO SELF-TEST is GJS.

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Other records listing Hemosense, 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.

K072727INRATIO 2 PT MONITORING SYSTEMK020679INRATIO

Related Devices (Code: GJS)

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.

K253188CoaguChek XS Plus SystemRoche DiagnosticsK251564microINR SystemIline Microsystems, S.L.K243543microINR SystemIline Microsystems, S.L.K230802Xprecia Prime Coagulation SystemUniversal Biosensors Pty, Ltd.K220282i-STAT PTplus Cartridge with the i-STAT 1 SystemAbbott LaboratoriesK231711microINR SystemIline Microsystems, S.L.

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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