CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE— 510(k) K962873

Name: FDA 510(k) clearance K962873
Creator: U.S. Food and Drug Administration
Published: 1997-01-13

Substantially Equivalent

Vysis

FDA 510(k) clearance K962873 for CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE, Substantially Equivalent on 1997-01-13. Applicant: Vysis. Device class: 2.

Clearance details

Applicant: Vysis
Product code: Code OVQ
Device class: Class 2
Regulation: 21 CFR 866.6040
Advisory panel: Immunology
Date received: 1996-07-23
Decision date: 1997-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Downers Grove, IL, US

Download summary PDF View on FDA.gov ↗

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