# Light Diagnostics

- Location (FDA's records): Temecula, CA
- FDA decisions: 19 (1993–1999): 19 510(k) clearances
- Product codes: GOE (5), GNM (4), DBL (2), GQN (1), LIN (1), GNW (1), GQX (1), GQH (1), GQW (1), GOI (1), GNY (1)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 5 (1 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Diagnostic Hybrids, Inc.: 3 (https://510kreport.com/company/diagnostic-hybrids)
- Diagnostic Products Corp.: 1 (https://510kreport.com/company/diagnostic-products)

## Its most-cited devices
- K951799: Varicella-Zoster Virus Direct Immunofluorescence Assay (1996), cited by 2
- K951821: Cytomegalovirus Direct Immunofluorescence Assay (1996), cited by 1
- K990141: Light Diagnostics Simulfluor HSV/VZV Immunoflourescence Assay, Model 3295 (1999), cited by 1
- K922801: Resp. Panel 1 Indirect Immunofluorescence Assay (1993), cited by 1

## Recent decisions
- K991880: Light Diagnostics Simulfluor HSV 1/2 Immunofluorecence Assay (Nov 9, 1999)
- K990141: Light Diagnostics Simulfluor HSV/VZV Immunoflourescence Assay, Model 3295 (Oct 19, 1999)
- K972975: Light Diagnostics Rabies Dfa Reagent (Dec 22, 1998)
- K974302: Light Diagnostics Simulfluor Flu a/Flu B (Apr 8, 1998)
- K951821: Cytomegalovirus Direct Immunofluorescence Assay (Jun 7, 1996)
- K951799: Varicella-Zoster Virus Direct Immunofluorescence Assay (Mar 20, 1996)
- K940026: Poliovirus Blend Monoclonal Antibodies (Sep 12, 1995)
- K940034: Poliovirus 2 Monoclonal Antibody (Sep 12, 1995)

Source page: https://510kreport.com/company/light-diagnostics