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GUIDANCE DOCUMENT

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 June 2015

Final
Docket Number:
FDA-2014-D-1242
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

FDA is issuing this guidance to provide industry and agency staff with recommendations for the suggested format and content of an Abbreviated 510(k) submission for early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization devices and recommendations for addressing certain labeling issues relevant to the review process specific to these devices.


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