Recognized standard
C29-A2 (Replaces C29-A)
FDA recognition 7-86 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-86 |
|---|---|
| Designation | C29-A2 (Replaces C29-A) |
| Title | Standardization of Sodium and Potassium Ion Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard - Second Edition |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | Mar 8, 2004 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard contains recommendations for the expression of results of ion-selective electrode measurement of sodium and potassium ion activities in undiluted serum, plasma, or whole blood in clinical practice. |
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: