# K905215: Immulite (TM) Automated Immunoassay Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Cirrus Diagnostics, Inc.
- Decided: Jan 11, 1991 after 52 days
- Product code: JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K022603: Immulite 1000 Automated Immunoassay Analyzer (2002), 1 descendant of its own
- K032881: Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total Testosterone (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K905215
Methodology: https://510kreport.com/methodology