# Kit Certification for 510(k)s - FDA Guidance Document

Source: https://www.keypedia.com/guidances/guidance-document/kit-certification-for-510ks/8f13b612-91ae-40b9-96fa-8b0088880ddb

> FDA guidance document: Kit Certification for 510(k)s. Issue date: June 30, 1997. Get complete insights and analysis.

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## Details

- Title: Kit Certification for 510(k)s
- Communication Type: Guidance Document
- Product Type: Medical Devices
- Office Name: Center for Devices and Radiological Health
- Issue Date: 1997-06-30
- Docket Number: FDA-2020-D-0957

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