# Inova Diagnostics, Inc.

- Location (FDA's records): San Diego, CA
- FDA decisions: 138 (1988–2026): 136 510(k) clearances and 2 De Novo grants
- Product codes: LLL (37), MVM (12), MID (9), MST (8), MOB (8), MSV (7), DHN (4), NHX (4), DHR (4), LSR (3), LJM (3), NXO (2)
- Predicates its devices cite: 42 (35 its own); citations of its devices by later devices: 103 (35 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Instrumentation Laboratory CO: 2 (https://510kreport.com/company/instrumentation-laboratory)
- Hycor Biomedical, Inc.: 1 (https://510kreport.com/company/hycor-biomedical)
- The Binding Site, Ltd.: 1 (https://510kreport.com/company/binding-site)
- Orgentec: 1 (https://510kreport.com/company/orgentec)
- Eurospital S.P.A.: 1 (https://510kreport.com/company/eurospital)
- Biomedical Diagnostics (Bmd) SA: 1 (https://510kreport.com/company/biomedical-diagnostics-bmd)

## Firms that cite its devices most
- Euroimmun Us, Inc.: 16 (https://510kreport.com/company/euroimmun-us)
- Bio-Rad Laboratories, Inc.: 11 (https://510kreport.com/company/bio-rad-laboratories)
- Phadia US, Inc.: 11 (https://510kreport.com/company/phadia-us)
- Sqi Diagnostics Systems: 7 (https://510kreport.com/company/sqi-diagnostics-systems)
- Phadia AB: 5 (https://510kreport.com/company/phadia)
- Rhigene, Inc.: 3 (https://510kreport.com/company/rhigene)
- Biomedical Diagnostics (Bmd) SA: 3 (https://510kreport.com/company/biomedical-diagnostics-bmd)
- Corgenix, Inc.: 3 (https://510kreport.com/company/corgenix)

## Its most-cited devices
- K981237: Quanta Lite Ribosome P Elisa (1998), cited by 5
- K052143: Quanta Lite Gliadin Iga II (2005), cited by 4
- K961340: Nova Lite Anca (1996), cited by 4
- K052142: Quanta Lite Gliadin Igg II (2005), cited by 4
- K970551: Quanta Lite B2GPI Igg (1997), cited by 4
- K052262: Quanta Lite M2 EP (MIT3) Elisa (2005), cited by 4

## Recent decisions
- K243979: Aptiva APS IgA Reagent (Feb 6, 2026)
- K223093: Aptiva APS IgG Reagent; Aptiva APS IgM Reagent (Dec 17, 2024)
- K213403: Aptiva CTD Essential Reagent (Sep 29, 2023)
- K200230: Aptiva Celiac Disease IgG Reagent (Aug 26, 2021)
- K193604: Aptiva Celiac Disease IgA Reagent (Jun 16, 2021)
- K192916: NOVA Lite DAPI dsDNA Crithidia luciliae Kit (Dec 11, 2020)
- K190088: QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents (Apr 17, 2019)
- K180971: QUANTA Flash Calprotectin and Fecal Extraction Device (Oct 16, 2018)

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