# Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s - Guidance for Industry and FDA Reviewers/Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/guidance-for-over-the-counter-otc-human-chorionic-gonadotropin-hcg-510ks-guidance-for-industry-and-fda-reviewersstaff/ea717772-1510-4c48-82e6-81e153b5f603

> FDA guidance document: Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s - Guidance for Industry and FDA Reviewers/Staff. Issue date: July 21, 2000. Get complete insights and analysis.

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## Details

- Title: Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s - Guidance for Industry and FDA Reviewers/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: 2000-07-21
- Last Changed: 2020-03-24
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2020-D-0957">FDA-2020-D-0957</a>

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