FDA guidance
Recommendations for Anti-Nuclear Antibody (ANA) Test System Premarket (510(k)) Submissions…
FDA guidance · issued Jan 22, 2009
Key facts
| Title | Recommendations for Anti-Nuclear Antibody (ANA) Test System Premarket (510(k)) Submissions - Guidance for Industry and FDA Staff |
|---|---|
| Issue date | Jan 22, 2009 |
At a glance
- 10–99 Product codes referenced
- 1–9 Recognized standards referenced
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA guidance documents
FDA guidance documents describe the agency's current thinking on regulatory topics. Drafts are issued for comment before a final version is published.
Source: U.S. Food and Drug Administration (FDA), Guidance Documents