Recognized standard
AUTO9-A
FDA recognition 13-28 · CLSI · Software/Informatics
Key facts
| Recognition number | 13-28 |
|---|---|
| Designation | AUTO9-A |
| Title | Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | Software/Informatics |
| Date of entry | Mar 18, 2009 |
| Device classes | Class 1 |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: