# Em Diagnostic Systems, Inc.

- Location (FDA's records): Gibbstown, NJ
- FDA decisions: 288 (1984–1994): 288 510(k) clearances
- Product codes: CIG (21), CGS (14), CDT (13), JQB (10), CKA (10), CJE (10), CHH (10), CIT (10), CEK (10), CEO (10), CGX (10), CFJ (10)
- 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
- K935181: Aspartate Aminotransferase (Ast) Test (Jan 27, 1994)
- K935180: Alanine Aminotransferase (Alt) Test (Jan 13, 1994)
- K935178: Emds Phosphorous (Phos) Test (Dec 17, 1993)
- K935179: Emds Albumin (Alb) Test (Dec 17, 1993)
- K935174: Total Protein Test (Tpro) (Dec 16, 1993)
- K935175: Lactate Dehydrogenase (LD) (Dec 16, 1993)
- K935177: Gamma-Glutamyl Transferase (GGT) Test (Dec 16, 1993)
- K935176: Iron Test (Dec 16, 1993)

Source page: https://510kreport.com/company/em-diagnostic-systems