# Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/recommendations-for-premarket-notification-510k-submissions-for-nucleic-acid-based-human-leukocyte-antigen-hla-test-kits-used-for-matching-of-donors-and-recipients-in-transfusion-and-transplantation-guidance-for-industry/c3991a09-4456-4aa7-9caf-359965bbb120

> FDA guidance document: Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation:  Guidance for Industry. Issue date: July 31, 2015. Get complete insights and analysis.

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## Details

- Title: Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation:  Guidance for Industry
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Biologics Evaluation and Research
- Office URL: /offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d
- Issue Date: 2015-07-31
- Last Changed: 2021-04-21
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2013-D-1358">FDA-2013-D-1358</a>

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