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FDA 510(k)

ANEUVYSION MULITICOLOR DNA PROBE KIT

K-Number: K010288 · 2001-04-13

ApplicantVysis
Decision Date2001-04-13
Product CodeOYU
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANEUVYSION MULITICOLOR DNA PROBE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Vysis. It received FDA 510(k) clearance on 2001-04-13 under 510(k) number K010288. The device is classified under product code OYU. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANEUVYSION MULITICOLOR DNA PROBE KIT?

ANEUVYSION MULITICOLOR DNA PROBE KIT is a medical device that received FDA 510(k) clearance on 2001-04-13. The listed applicant is Vysis. The 510(k) number is K010288.

When did ANEUVYSION MULITICOLOR DNA PROBE KIT receive FDA 510(k) clearance?

ANEUVYSION MULITICOLOR DNA PROBE KIT received FDA 510(k) clearance on 2001-04-13, under 510(k) number K010288.

Who is the listed applicant for ANEUVYSION MULITICOLOR DNA PROBE KIT?

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 ANEUVYSION MULITICOLOR DNA PROBE KIT?

The FDA product code for ANEUVYSION MULITICOLOR DNA PROBE KIT is OYU.

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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.

K033982MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TESTK013785UROVYSION BLADDER CANCER RECURRENCE KITK011031VYSIS UROVYSION BLADDER CANCER RECURRENCE KITK972200ANEUVYSIONK954214CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KITK962873CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE

View all 8 devices →

Related Devices (Code: OYU)

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.

K972200ANEUVYSIONVysisK953591CEP 8 SPECTRUMORANGE DNA PROBE KITVysis

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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