# K952637: Qualicheck 4 Glucose

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer America, Inc.
- Decided: Sep 5, 1995 after 88 days
- Product code: JJS (Controls For Blood-Gases, (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.
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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K961354: Qualicheck 4 Metabolite (S3630,S3640,S3650,S3660) (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K952637
Methodology: https://510kreport.com/methodology