# Biological Indicator (BI) Premarket Notification [510(k)] Submissions :  Guidance for Industry and FDA Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/biological-indicator-bi-premarket-notification-510k-submissions-guidance-for-industry-and-fda-staff/51018101-f28f-48a6-9a97-175cb14cee50

> FDA guidance document: Biological Indicator (BI) Premarket Notification [510(k)] Submissions :  Guidance for Industry and FDA Staff. Issue date: October 04, 2007. Get complete insights and analysis.

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## Details

- Title: Biological Indicator (BI) Premarket Notification [510(k)] Submissions :  Guidance for Industry and FDA 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: 2007-10-04
- Last Changed: 2020-03-19
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2020-D-0957">FDA-2020-D-0957</a>

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