# K910198: Ciba Corning Acs LH Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Corning Diagnostics Corp.
- Decided: Feb 4, 1991 after 19 days
- Product code: CEP (Radioimmunoassay, Luteinizing Hormone)
- Device class: 1
- Regulation: 21 CFR 862.1485
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K962041: Acs LH2 Immunoassay (1996), 1 descendant of its own
- K101460: Loci 8 Calibrator, Model KC 646 (2010), 0 descendants of its own

Source page: https://510kreport.com/device/K910198
Methodology: https://510kreport.com/methodology