Recognized standard
LIS04-A
FDA recognition 13-19 · CLSI · Software/Informatics
Key facts
| Recognition number | 13-19 |
|---|---|
| Designation | LIS04-A |
| Title | Standard Guide for Documentation of Clinical Laboratory Computer Systems |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | Software/Informatics |
| Date of entry | Sep 9, 2008 |
| Device classes | Class 1 |
At a glance
- 1–9 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: