# K964558: Vitros Immunodiagnostics Products/TSH Reagent Pack (Gem. 1001)/TSH Calibrators (Gem.C001)

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Clinical Diagnostics, Inc.
- Decided: Dec 16, 1996 after 33 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 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
- K081543: Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 5600 Integrated System (2008), 3 descendants of its own
- K182063: VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System (2018), 1 descendant of its own
- K190326: VITROS XT Chemistry Products UREA-CREA Slides (2019), 0 descendants of its own
- K083173: Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 3600 Immunodiagnostic System (2008), 0 descendants of its own

Source page: https://510kreport.com/device/K964558
Methodology: https://510kreport.com/methodology