# K970016: Vitros Immunodiagnositcs Products-Free T3 Reagent Pack (Gem.1020)/Free T3 Calibrators (Gem.C020)

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Clinical Diagnostics, Inc.
- Decided: Jan 30, 1997 after 28 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K994145: Vitros Immunodiagnostic Products Free T3 Reagent Pack, Vitros Immunodiagnostic Products Free T3 Calibrators (1999), 0 descendants of its own

## Recalls of this device
- Apr 9, 2024 · Class II · Z-1818-2024: T3 Reagent Packs used with Free T3 Calibrators may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testin

Source page: https://510kreport.com/device/K970016
Methodology: https://510kreport.com/methodology