Recognized standard
C24 4th Edition (Replaces C24-A3)
FDA recognition 7-267 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-267 |
|---|---|
| Designation | C24 4th Edition (Replaces C24-A3) |
| Title | Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Dec 23, 2016 |
| Device classes | Class 1 |
| Scope (excerpt) | This guideline provides definitions, principles, and approaches to laboratory quality control design, implementation, and assessment. |
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: