FDA 510(k)

CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT

K-Number: K954214 · 1997-01-21

ApplicantVysis

Decision Date1997-01-21

Product CodeOXP

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

CEP X SPECTRUMORANGE\Y SPECTRUMGREEN 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 1997-01-21 under 510(k) number K954214. The device is classified under product code OXP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT?

CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT is a medical device that received FDA 510(k) clearance on 1997-01-21. The listed applicant is Vysis. The 510(k) number is K954214.

When did CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT receive FDA 510(k) clearance?

CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT received FDA 510(k) clearance on 1997-01-21, under 510(k) number K954214.

Who is the listed applicant for CEP X SPECTRUMORANGE\Y SPECTRUMGREEN 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 CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT?

The FDA product code for CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT is OXP.

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Other records listing Vysis as applicant

K033982MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST K013785UROVYSION BLADDER CANCER RECURRENCE KIT K011031VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT K010288ANEUVYSION MULITICOLOR DNA PROBE KIT K972200ANEUVYSION K962873CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.