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FDA 510(k)

MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST

K-Number: K033982 · 2004-01-22

ApplicantVysis
Decision Date2004-01-22
Product CodeMMW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Vysis. It received FDA 510(k) clearance on 2004-01-22 under 510(k) number K033982. The device is classified under product code MMW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST?

MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST is a medical device that received FDA 510(k) clearance on 2004-01-22. The listed applicant is Vysis. The 510(k) number is K033982.

When did MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST receive FDA 510(k) clearance?

MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST received FDA 510(k) clearance on 2004-01-22, under 510(k) number K033982.

Who is the listed applicant for MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST?

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

What is the FDA product code for MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST?

The FDA product code for MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST is MMW.

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Other records listing Vysis 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.

K013785UROVYSION BLADDER CANCER RECURRENCE KITK011031VYSIS UROVYSION BLADDER CANCER RECURRENCE KITK010288ANEUVYSION MULITICOLOR DNA PROBE KITK972200ANEUVYSIONK954214CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KITK962873CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE

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Related Devices (Code: MMW)

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.

K203245Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03CNucleix , Ltd.K021231NMP22 BLADDERCHEK KIT, NMP22 CONTROL KITMatritech, Inc.K013785UROVYSION BLADDER CANCER RECURRENCE KITVysisK011031VYSIS UROVYSION BLADDER CANCER RECURRENCE KITVysisK974845BTA STAT TEST PRESCRIPTION HOME USEBard Diagnostic Sciences,Inc.K971402BARD BTA TRAK TESTBard Diagnostic Sciences,Inc.

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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