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FDA 510(k)

COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING

K-Number: K030845 · 2003-05-22

ApplicantRoche Diagnostics Corp.
Decision Date2003-05-22
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2003-05-22 under 510(k) number K030845. 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 COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING?

COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING is a medical device that received FDA 510(k) clearance on 2003-05-22. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K030845.

When did COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING receive FDA 510(k) clearance?

COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING received FDA 510(k) clearance on 2003-05-22, under 510(k) number K030845.

Who is the listed applicant for COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING?

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

What is the FDA product code for COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING?

The FDA product code for COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING is GJS.

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Related Devices (Code: GJS)

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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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