The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``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.'' This guidance provides industry and Agency staff with recommendations for the suggested format and content of an abbreviated 510(k) submission for EGR1 gene FISH test system for specimen characterization devices.
Document
Content and Format of Abbreviated 510(k)s for Early Growth Response 1 Gene Fluorescence In-Situ Hybridization Test System for Specimen Characterization Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Ge...
Legal Citation
Federal Register Citation
Use this for formal legal and research references to the published document.
80 FR 34678
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Content and Format of Abbreviated 510(k)s for Early Growth Response 1 Gene Fluorescence In-Situ Hybridization Test System for Specimen Characterization Devices; Guidance for Industry and Food and Drug Administration Staff; Availability,” thefederalregister.org (June 17, 2015), https://thefederalregister.org/documents/2015-14881/content-and-format-of-abbreviated-510-k-s-for-early-growth-response-1-gene-fluorescence-in-situ-hybridization-test-syste.