# K934361: Olympus Creatinine Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Corp.
- Decided: Nov 16, 1993 after 69 days
- Product code: CGX (Alkaline Picrate, Colorimetry, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K200898: Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin (2021), 1 descendant of its own
- K110530: Abx Pentra Creatinine 120 CP; Abx Pentra Multical;  Abx Pentra N Control; Abx Pentra P Control; Abx Pentra Urine Control (2012), 1 descendant of its own
- K251157: Core Metabolic (2026), 0 descendants of its own
- K191396: Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe (2019), 0 descendants of its own

## Recalls of this device
- Dec 28, 2012 · Class II · Z-0958-2013: Beckman Coulter is including additional information and instructions in the Creatinine (OSR6x78) IFU and Setting Sheet, relating to calibration stability and quality control frequency to assure produc

Source page: https://510kreport.com/device/K934361
Methodology: https://510kreport.com/methodology