# K960412: T-3 Microwell Eia Model 7013

- Pathway: 510(k) (Traditional)
- Applicant: Biomerica, Inc.
- Decided: Mar 19, 1996 after 50 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) T3 Coat-a-Count RIA test (DPC kit): named in the summary without a submission number

## Indications for use
Biomerica’s T3 microwell EIA is Enzyme Immuno-assay test for the quantitative determination of Triiodothyronine (T3 ) in human serum.

Source page: https://510kreport.com/device/K960412
Methodology: https://510kreport.com/methodology