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FDA 510(k)

PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422

K-Number: K021190 · 2002-10-25

ApplicantRoche Diagnostics Corp.
Decision Date2002-10-25
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422 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 2002-10-25 under 510(k) number K021190. 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 PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422?

PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422 is a medical device that received FDA 510(k) clearance on 2002-10-25. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K021190.

When did PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422 receive FDA 510(k) clearance?

PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422 received FDA 510(k) clearance on 2002-10-25, under 510(k) number K021190.

Who is the listed applicant for PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422?

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 PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422?

The FDA product code for PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422 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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