# K013420: Chemwell, Also Known as Project 2900

- Pathway: 510(k) (Abbreviated)
- Applicant: Awareness Technology, Inc.
- Decided: Jul 19, 2002 after 277 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
ChemWell will be used by laboratory technologists to obtain blood chemistry information from patient serum samples. The following quantitative UBI ELISA kits are included in this 510(k): thyroid stimulating hormone (TSH), total triiodothyronine (T3) and total thyroxine (T4). The measurement of these hormones is used for the diagnosis of thyroid disorders.

Source page: https://510kreport.com/device/K013420
Methodology: https://510kreport.com/methodology