# K913470: Cedia (R) Gentamicin Assay

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Sep 27, 1991 after 53 days
- Product code: LCD (Enzyme Immunoassay, Gentamicin)
- Device class: 2
- Regulation: 21 CFR 862.3450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K963191: Cedia Antibiotic TDM Multi-Cals (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K913470
Methodology: https://510kreport.com/methodology