Class Class II
GEM Premier ChemSTAT (K223090)
Description
GEM Premier ChemSTAT by Instrumentation Laboratory CO, an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223090
Clearance Date2023-01-27
Clearance TypeSpecial
Product CodeCGA
Regulation Number862.1345
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223090
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. GEM Premier ChemSTAT (K223090) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K183546 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2019 |
| K183549 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2019 |
| K183555 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2019 |
Trace the full predicate network for K223090
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.