# K992252: Light Diagnostics Pneumocystis Carinii Dfa, Model 31965

- Pathway: 510(k) (Special)
- Applicant: Chemicon Intl., Inc.
- Decided: Aug 10, 1999 after 35 days
- Product code: LYF (Pneumocystis Carinii)
- Device class: 2
- Regulation: 21 CFR 866.3780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Light Diagnostics Pneumocystis carinii DFA intended use is an in vitro procedure for the detection of Preumocystis carinii cysts and trophozoites in direct smears of respiratory tract specimens including sputum, bronchoaveolar lavage, and lung biopsy.

Source page: https://510kreport.com/device/K992252
Methodology: https://510kreport.com/methodology