Recognized standard
H20-A2 (Replaces H20-A)
FDA recognition 7-165 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-165 |
|---|---|
| Designation | H20-A2 (Replaces H20-A) |
| Title | Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard - Second Edition |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Mar 16, 2012 |
| Device classes | Class 2 |
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: