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FDA 510(k)

INRATIO

K-Number: K020679 · 2002-05-06

ApplicantHemosense, Inc.
Decision Date2002-05-06
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

INRATIO is the device name listed in this FDA 510(k) record. The listed applicant is Hemosense, Inc.. It received FDA 510(k) clearance on 2002-05-06 under 510(k) number K020679. 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?

INRATIO is a medical device that received FDA 510(k) clearance on 2002-05-06. The listed applicant is Hemosense, Inc.. The 510(k) number is K020679.

When did INRATIO receive FDA 510(k) clearance?

INRATIO received FDA 510(k) clearance on 2002-05-06, under 510(k) number K020679.

Who is the listed applicant for INRATIO?

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?

The FDA product code for INRATIO is GJS.

Related Clinical Trials

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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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 SYSTEMK021923INRATIO SELF-TEST

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

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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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