FDA guidance
Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators
FDA guidance · issued Feb 22, 1999
Key facts
| Title | Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators |
|---|---|
| Issue date | Feb 22, 1999 |
| Document on fda.gov | wayback.archive-it.org |
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