# Genbio

- Location (FDA's records): San Diego, CA
- FDA decisions: 10 (1996–2001): 10 510(k) clearances
- Product codes: LSE (4), LJZ (2), LSR (2), LJN (1), LLM (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
- K010301: Immunowell EA (D) Igg Test (Jun 11, 2001)
- K974244: Immunodot Mono-M Test (Sep 22, 1998)
- K974226: Immunodot Mono-G Test (Sep 22, 1998)
- K973940: Immunowell Ebv Vca Igg Test (Aug 10, 1998)
- K973939: Immunowell Vca Igm Test (Aug 10, 1998)
- K973941: Immunowell Ebna Igg Test (Aug 10, 1998)
- K963054: Immunowell Mycoplasma Pneumonia Antibody (Igm) Test (3130) (May 5, 1997)
- K963055: Immunowell Mycoplasma Pneumonia Antibody (Igg) Test 3120 (May 2, 1997)

Source page: https://510kreport.com/company/genbio