# K083373: Immulite 2000 Free T4

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Feb 2, 2009 after 80 days
- Product code: CEC (Radioimmunoassay, Free Thyroxine)
- Device class: 2
- Regulation: 21 CFR 862.1695
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K902336 (1990). 3 ancestors in all.
1 later device descends from it; 1 cites 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)
- K961510: Acs FRT4 Immunoassay, Ciba Corning Diagnostics Corp. (1996) Summary page 2.
- K971418: Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur Analyzer, Chiron Diagnostics Corp. (1997) Summary page 2.

## Most influential descendants
- K160647: IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 (2016), 0 descendants of its own

## Indications for use
The IMMULITE® 2000 Free Thyroxine Assay is for in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers - for the quantitative measurement of non-protein-bound thyroxine (free T4) in serum and heparinized plasma, as an aid in the clinical assessment of thyroid status.

Source page: https://510kreport.com/device/K083373
Methodology: https://510kreport.com/methodology