# 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 - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/content-and-format-for-abbreviated-510ks-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/48e4f4e5-6d04-47ee-991d-451e7fafc090

> FDA 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. Issue date: June 17, 2015. Get complete insights and analysis.

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## Details

- Title: 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
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2015-06-17
- Last Changed: 2019-04-11
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2014-D-1242">FDA-2014-D-1242</a>

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