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FDA 510(k)

CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE

K-Number: K962873 · 1997-01-13

ApplicantVysis
Decision Date1997-01-13
Product CodeOVQ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Vysis. It received FDA 510(k) clearance on 1997-01-13 under 510(k) number K962873. The device is classified under product code OVQ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE?

CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE is a medical device that received FDA 510(k) clearance on 1997-01-13. The listed applicant is Vysis. The 510(k) number is K962873.

When did CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE receive FDA 510(k) clearance?

CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE received FDA 510(k) clearance on 1997-01-13, under 510(k) number K962873.

Who is the listed applicant for CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE?

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 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE?

The FDA product code for CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE is OVQ.

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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

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Related Devices (Code: OVQ)

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.

K100015VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34Abbott Molecular, 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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