# K970539: Chiron Diagnostics Acs:180TU P

- Pathway: 510(k) (Traditional)
- Applicant: Chiron Diagnostics Corp.
- Decided: Mar 24, 1997 after 40 days
- Product code: KHQ (Radioassay, Triiodothyronine Uptake)
- Device class: 2
- Regulation: 21 CFR 862.1715
- 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 K925257 (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)
- K925257: Ciba Corning Acs T Uptake Immunoassay, Ciba Corning Diagnostics Corp. (1992) Summary page 1.

## Indications for use
For the assessment of unsaturated thyroid binding proteins in serum or plasma using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems.

Source page: https://510kreport.com/device/K970539
Methodology: https://510kreport.com/methodology