# K960913: Access Free T3 Assay

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Mar 29, 1996 after 23 days
- Product code: CDP (Radioimmunoassay, Total Triiodothyronine)
- Device class: 2
- Regulation: 21 CFR 862.1710
- Recalls of this device: 1 (0 Class I)
- 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) Magic® 1-Free T3 Radioimmunoassay: named in the summary without a submission number

## Recalls of this device
- Aug 31, 2015 · Class II · Z-0110-2016: Beckman Coulter, Inc. is recalling Access Free T3 Reagent Kit because they were filled incorrectly and contain insufficient quantity of reagents in one or more of the pack wells.

## Indications for use
The ACCESS® Free T3 assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of free trilodothyronine levels in human serum using the ACCESS® Immunoassay System. The Access® Free T3 assay aids in the diagnosis of hyperthyroidism.

Source page: https://510kreport.com/device/K960913
Methodology: https://510kreport.com/methodology