Regulations.gov document
Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based…
Notice · FDA-2013-D-1358 · posted Aug 3, 2015
Key facts
| Document ID | FDA-2013-D-1358-0008 |
|---|---|
| Title | Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation; Guidance for Industry; Availability |
| Document type | Notice |
| Subtype | Notice of Availability |
| Agency | FDA |
| Docket | FDA-2013-D-1358 |
| Posted | Aug 3, 2015 |
| Federal Register citation | 80 FR 46032 |
| FR document number | 2015-18956 |
| Comment period opens | Aug 3, 2015 |
| Effective date | Aug 3, 2015 |
At a glance
- 1–9 Pages
- 1–9 Public comments on this docket
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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