VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34— 510(k) K100015

Name: FDA 510(k) clearance K100015
Creator: U.S. Food and Drug Administration
Published: 2011-08-09

Substantially Equivalent

Abbott Molecular, Inc.

FDA 510(k) clearance K100015 for VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34, Substantially Equivalent on 2011-08-09. Applicant: Abbott Molecular, Inc.. Device class: 2.

Clearance details

Applicant: Abbott Molecular, Inc.
Product code: Code OVQ
Device class: Class 2
Regulation: 21 CFR 866.6040
Advisory panel: Immunology
Date received: 2010-01-04
Decision date: 2011-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, US

Download summary PDF View on FDA.gov ↗

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