# K912648: ISE/NA+

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jul 17, 1991 after 30 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.
21 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K963627: (Modified Version) Integra Ion Selective Electrode (Ise) Module (1996), 20 descendants of its own
- K052007: Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module) (2005), 15 descendants of its own
- K060854: Abx Pentra 400:  Lipoproteins (2006), 3 descendants of its own
- K123171: Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra N Control, and Abx Pentra P Cont (2013), 2 descendants of its own
- K123726: Cobas 8000 Ise Indirect NA, K, CI for Gen. 2 (2013), 1 descendant of its own

Source page: https://510kreport.com/device/K912648
Methodology: https://510kreport.com/methodology