# K981425: Stat Profile Ultra a, B, C, D, and E Analyzers

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corp.
- Decided: May 12, 1998 after 26 days
- Product code: GKF (Instrument, Hematocrit, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The StatProfile Ultra A,B,C,D and E Analyzers are intended for in vitro diagnostic use by health care professionals in the quantitative determination of sodium, potassium, ionized calcium, ionized magnesium, glucose, lactate, pH, PCO2, PO2, oxygen saturation, lactate, hemoglobin and hematocrit in serum, plasma and whole blood. intended for Point-of-Care Usage

Source page: https://510kreport.com/device/K981425
Methodology: https://510kreport.com/methodology