# Disease Detection International, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 20 (1988–1994): 20 510(k) clearances
- Product codes: JHI (6), LFX (3), LGD (2), LFZ (2), LGC (2), GQO (1), CEP (1), GTZ (1), LCX (1), LYF (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K943252: Pro-Step LH Ovulation Prediction Test (Oct 25, 1994)
- K925303: Pro-Step PT HCG (Jun 15, 1993)
- K925125: Pro-Step HCG (Jan 13, 1993)
- K911826: Immunocard HCG One Step (I-S) Test Kit (Jul 19, 1991)
- K902571: Modification of Serocard Rubella Igg Test (Sep 5, 1990)
- K903070: Serocard HSV Igg Antibody Test Kit (Aug 9, 1990)
- K895912: Immunocard HCG II-S Test Kit (Dec 1, 1989)
- K896109: Immunocard Strep a Test (Nov 29, 1989)

Source page: https://510kreport.com/company/disease-detection-international