# K962719: Hycor HY.Tec/Manual SS-a Auto-Antibody

- Pathway: 510(k) (Traditional)
- Applicant: Hycor Biomedical, Inc.
- Decided: Mar 7, 1997 after 249 days
- Product code: LLL (Extractable Antinuclear Antibody, Antigen And Control)
- Device class: 2
- Regulation: 21 CFR 866.5100
- 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
- K141328: Quanta Flash RO60, Quanta Flash RO60 Calibrators, Quanta Flash RO60 Controls (2015), 3 descendants of its own
- K253817: IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La (2026), 0 descendants of its own
- K213403: Aptiva CTD Essential Reagent (2023), 0 descendants of its own
- K210902: EliA Ro52, EliA Ro60 (2022), 0 descendants of its own

Source page: https://510kreport.com/device/K962719
Methodology: https://510kreport.com/methodology