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.

Clearance details

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

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