CEP 8 SPECTRUMORANGE DNA PROBE KIT— 510(k) K953591

Substantially Equivalent

Vysis

FDA 510(k) clearance K953591 for CEP 8 SPECTRUMORANGE DNA PROBE KIT, Substantially Equivalent on 1996-11-29. Applicant: Vysis. Device class: 2.

Clearance details

Applicant: Vysis
Product code: Code OYU
Device class: Class 2
Regulation: 21 CFR 866.4700
Advisory panel: Immunology
Date received: 1995-08-01
Decision date: 1996-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Downers Grove, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OYU

K010288 — ANEUVYSION MULITICOLOR DNA PROBE KIT2001-04-13
K972200 — ANEUVYSION1997-10-20

More clearances from Vysis

DEN040010 — VYSIS AUTOVYSION SYSTEM2004-12-13
K033982 — MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST2004-01-22
K013785 — UROVYSION BLADDER CANCER RECURRENCE KIT2002-02-08
K011031 — VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT2001-08-03
K954214 — CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT1997-01-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.