# K970894: Vitros Immunodiagnostics Products Total B-HCG Reagent Pack (Gem.1075), Total B-HCG Calibrators (Gem.C075)

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Clinical Diagnostics, Inc.
- Decided: Apr 14, 1997 after 34 days
- Product code: DHA (System, Test, Human Chorionic Gonadotropin)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K063720: Vitros Immunodiagnostic Products Total B-HCG II Reagent Pack, Calibrators, Range Verifiers (2007), 1 descendant of its own
- K233581: VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack (2024), 0 descendants of its own

Source page: https://510kreport.com/device/K970894
Methodology: https://510kreport.com/methodology