FDA-recognized standard · Software/Informatics
IEEE 11073-10422-2016: Health informatics - Personal health device communication Part 10422: Device Specialization - Urine Analyzer
Yes. FDA recognizes IEEE Std 11073-10422-2016 as recognition 13-93, entered 2017-08-21.
Recognized editions of IEEE 11073-10422-2016
| Recognition | Edition | Entered | Extent | Transition ends |
|---|---|---|---|---|
| 13-93 | IEEE Std 11073-10422-2016 also ISO IEEE 11073-10422:2017 | 2017-08-21 | Complete | — |
Regulations
FDA lists these classification regulations against IEEE 11073-10422-2016: 21 CFR 862.1115, 21 CFR 862.1340, 21 CFR 862.1435, 21 CFR 862.1510, 21 CFR 862.1550, 21 CFR 862.1645, 21 CFR 862.1785, 21 CFR 864.6550, 21 CFR 864.7675.
Product codes that cite IEEE 11073-10422-2016
9 FDA product codes cite IEEE 11073-10422-2016, including CDM, CEN, JIL, JIN, JIO.
- CDM
- CEN
- JIL
- JIN
- JIO
- JIR
- JJB
- JMT
- LJX
Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.