# K934641: I-Stat Control  Levels 1,2,3

- Pathway: 510(k) (Traditional)
- Applicant: I-Stat Corp.
- Decided: Dec 9, 1993 after 79 days
- Product code: JJR (Electrolyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K961195: Chem-Chex Stat (1996), 2 descendants of its own
- K993321: R&D HGB/GLC Whole Blood Control (1999), 1 descendant of its own
- K034048: R&D Glu-Line Hematology Control (2004), 0 descendants of its own
- K982290: Chem-Chex Stat (New) (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K934641
Methodology: https://510kreport.com/methodology