# K965213: Stratus Myoglobin Gluorometric Enzyme Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Dade Intl., Inc.
- Decided: Feb 10, 1997 after 42 days
- Product code: DDR (Myoglobin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5680
- 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 K922125 (1992). 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)
- K922125: Stratus Myoglobin Fluorometric Enzyme Immunoassay, Baxter Diagnostics, Inc. (1992) Summary page 1.

Source page: https://510kreport.com/device/K965213
Methodology: https://510kreport.com/methodology