# K933862: Ace (TM) Clin Chem Syst W/Opt Ion Select Electr (Ise)

- Pathway: 510(k) (Traditional)
- Applicant: Schiapparelli Biosystems, Inc.
- Decided: Oct 12, 1993 after 64 days
- Product code: JGS (Electrode, Ion Specific, Sodium)
- Device class: 2
- Regulation: 21 CFR 862.1665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K123018: Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion Selective Electrode (Ise) Module (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K933862
Methodology: https://510kreport.com/methodology