# K030035: Irma SL Blood Analysis System CR Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Diametrics Medical, Inc.
- Decided: Jun 25, 2003 after 173 days
- Product code: JFY (Enzymatic Method, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- 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 K875191 (1988). 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)
- K875191: Kodak Ektachem DT Slides (CRSC), Eastman Kodak Company (1988) Summary page 1.

## Indications for use
Creatinine measurements are used in the diagnosis and treatment of certain renal disease, and in monitoring renal dialysis.

Source page: https://510kreport.com/device/K030035
Methodology: https://510kreport.com/methodology