FDA guidance
Class II Special Controls Guidance Document: Premarket Notifications for Automated…
FDA guidance · issued Dec 3, 2001
Key facts
| Title | Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells - Final Guidance for Industry and FDA |
|---|---|
| Issue date | Dec 3, 2001 |
At a glance
- 1–9 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