# K991692: Chiron Diagnostics Acs: 180 FT3

- Pathway: 510(k) (Traditional)
- Applicant: Chiron Diagnostics Corp.
- Decided: Jun 18, 1999 after 31 days
- Product code: CDP (Radioimmunoassay, Total Triiodothyronine)
- Device class: 2
- Regulation: 21 CFR 862.1710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Chiron Diagnostics ACS: 180 FT3 Immunoassay: named in the summary without a submission number

## Indications for use
For the quantitative determination of free triiodothyronine (FT3) in serum using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems. Measurements obtained by this test are used in the diagnosis and treatment of thyroid diseases.

Source page: https://510kreport.com/device/K991692
Methodology: https://510kreport.com/methodology