# K970393: Thyroid Stimulating Hormone Method

- Pathway: 510(k) (Traditional)
- Applicant: Dade Chemistry Systems, Inc.
- Decided: Mar 3, 1997 after 28 days
- Product code: JLW (Radioimmunoassay, Thyroid-Stimulating Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1690
- 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) Abbott AXSYM® Ultrasensitive hTSH: named in the summary without a submission number

## Indications for use
The TSH method is used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to quantitatively measure TSH in human serum and plasma. Measurements of TSH aid in the diagnosis of thyroid or pituitary disorders.

Source page: https://510kreport.com/device/K970393
Methodology: https://510kreport.com/methodology