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FDA 510(k)

CEP 8 SPECTRUMORANGE DNA PROBE KIT

K-Number: K953591 · 1996-11-29

ApplicantVysis
Decision Date1996-11-29
Product CodeOYU
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CEP 8 SPECTRUMORANGE 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 1996-11-29 under 510(k) number K953591. 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 CEP 8 SPECTRUMORANGE DNA PROBE KIT?

CEP 8 SPECTRUMORANGE DNA PROBE KIT is a medical device that received FDA 510(k) clearance on 1996-11-29. The listed applicant is Vysis. The 510(k) number is K953591.

When did CEP 8 SPECTRUMORANGE DNA PROBE KIT receive FDA 510(k) clearance?

CEP 8 SPECTRUMORANGE DNA PROBE KIT received FDA 510(k) clearance on 1996-11-29, under 510(k) number K953591.

Who is the listed applicant for CEP 8 SPECTRUMORANGE 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 8 SPECTRUMORANGE DNA PROBE KIT?

The FDA product code for CEP 8 SPECTRUMORANGE DNA PROBE KIT is OYU.

Related Clinical Trials

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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 KITK010288ANEUVYSION MULITICOLOR DNA PROBE KITK972200ANEUVYSIONK954214CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT

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.

K010288ANEUVYSION MULITICOLOR DNA PROBE KITVysisK972200ANEUVYSIONVysis

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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