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FDA 510(k)

INRATIO/INRATIO2 TEST STRIPS

K-Number: K092987 · 2010-06-11

ApplicantBiosite Incorporated
Decision Date2010-06-11
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

INRATIO/INRATIO2 TEST STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Biosite Incorporated. It received FDA 510(k) clearance on 2010-06-11 under 510(k) number K092987. 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/INRATIO2 TEST STRIPS?

INRATIO/INRATIO2 TEST STRIPS is a medical device that received FDA 510(k) clearance on 2010-06-11. The listed applicant is Biosite Incorporated. The 510(k) number is K092987.

When did INRATIO/INRATIO2 TEST STRIPS receive FDA 510(k) clearance?

INRATIO/INRATIO2 TEST STRIPS received FDA 510(k) clearance on 2010-06-11, under 510(k) number K092987.

Who is the listed applicant for INRATIO/INRATIO2 TEST STRIPS?

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

What is the FDA product code for INRATIO/INRATIO2 TEST STRIPS?

The FDA product code for INRATIO/INRATIO2 TEST STRIPS is GJS.

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Other records listing Biosite Incorporated 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.

K092048ONE STEP EDDP (METHADONE METABOLITE) TEST STRIPK093032TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SETK080269TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELSK072892TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5K062840TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLSK062530TRIAGE PROTEIN C TEST

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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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