# K900779: Enzymun Test (R) LH

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Apr 3, 1990 after 42 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.
15 later devices descend from it; 1 cites it directly.
0 of 16 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
- K964694: Elecsys LH Assay (1997), 14 descendants of its own
- K031299: Elecsys LH Calset II (2003), 13 descendants of its own
- K033873: Elecsys C-Peptide Calset (2004), 12 descendants of its own
- K103221: Elecys HGH Calset, Elecsys HGH Calcheck 5 (2010), 10 descendants of its own
- K113546: Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys Vitamin D Calcheck 5 (2012), 8 descendants of its own

Source page: https://510kreport.com/device/K900779
Methodology: https://510kreport.com/methodology