# K961354: Qualicheck 4 Metabolite (S3630,S3640,S3650,S3660)

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer America, Inc.
- Decided: Jun 14, 1996 after 67 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
Longest line of descent: 1 generation back to K952637 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952637: Qualicheck 4 Glucose, Radiometer America, Inc. (1995) Summary page 1.

## Indications for use
Qualicheck 4 Metabolite is intended for checking the precision and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood Gases, Electrolytes, Glucose and Lactate.

Source page: https://510kreport.com/device/K961354
Methodology: https://510kreport.com/methodology