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FDA 510(k)

INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP

K-Number: K110212 · 2012-05-01

ApplicantAlere San Diego, Inc (Formally Biosite Incorporate
Decision Date2012-05-01
Product CodeGJS
Advisory CommitteeHE
DecisionUnknown

Device Summary

INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Alere San Diego, Inc (Formally Biosite Incorporate. It received FDA 510(k) clearance on 2012-05-01 under 510(k) number K110212. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP?

INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP is a medical device that received FDA 510(k) clearance on 2012-05-01. The listed applicant is Alere San Diego, Inc (Formally Biosite Incorporate. The 510(k) number is K110212.

When did INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP receive FDA 510(k) clearance?

INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP received FDA 510(k) clearance on 2012-05-01, under 510(k) number K110212.

Who is the listed applicant for INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP?

The FDA 510(k) record lists Alere San Diego, Inc (Formally Biosite Incorporate as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP?

The FDA product code for INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP is GJS.

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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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