FDA Guidance Documents·· 原文未提供具体时分
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
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
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FDA 官方历史目录记录；Final guidance；发布日期：2015-06-17。官方主题：Premarket, 510(k), Labeling, Laboratory Tests, IVDs (In Vitro Diagnostic Devices), Molecular and Clinical Genetics, Immunology & Microbiology。请通过官方原文与附件查阅文件。
来源：FDA Guidance Documents · fda.gov