CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT— 510(k) K954214

Name: FDA 510(k) clearance K954214
Creator: U.S. Food and Drug Administration
Published: 1997-01-21

Substantially Equivalent

Vysis

FDA 510(k) clearance K954214 for CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT, Substantially Equivalent on 1997-01-21. Applicant: Vysis. Device class: 2.

Clearance details

Applicant: Vysis
Product code: Code OXP
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 1995-09-07
Decision date: 1997-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Downers Grove, IL, US

Download summary PDF View on FDA.gov ↗

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