Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Labeling, Microbiology, Premarket
Published
June 17, 2015
Last updated
April 11, 2019
Description
This is a guidance document titled "Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices" that covers topics like labeling, microbiology, and premarket.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)