Class Class II
EasyStat 300 (K211559)
Description
EasyStat 300 by Medica Corporation, an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK211559
Clearance Date2023-01-27
Clearance TypeTraditional
Product CodeCHL
Regulation Number862.1120
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K211559
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. EasyStat 300 (K211559) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K021515 | EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER | Medica Corp. | 2002 |
Trace the full predicate network for K211559
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.