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U.S. Department of Health and Human Services

Medical Devices

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Review Criteria for In Vitro Diagnostic Devices that Utilize Cytogenetic In Situ Hybridization Technology for the Detection of Human Genetic Mutations (Germ Line and Somatic)

Issued February 15, 1996

This document is in a Portable Document Format (PDF) and is divided into 3 parts. Acrobat Reader is required to read this document.

Part 1

 

Part 2

 

Part 3