# K961195: Chem-Chex Stat

- Pathway: 510(k) (Traditional)
- Applicant: Streck Laboratories, Inc.
- Decided: May 15, 1996 after 49 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- 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
Longest line of descent: 1 generation back to K934641 (1993). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934641: I-Stat Control  Levels 1,2,3, I-Stat Corp. (1993) Summary page 1.

## Most influential descendants
- 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

## Indications for use
Chem-Chex STAT is intended to be used for verifying the accuracy of i-STAT chemistry analyzers used with 6+ test cartridges. Chem-Chex STAT is assayed for Na+ Cl- K+ BUN, Hgb, Hct, and Glucose.

Source page: https://510kreport.com/device/K961195
Methodology: https://510kreport.com/methodology