# Diagnostic Systems

- Location (FDA's records): Gibbstown, NJ
- FDA decisions: 14 (1983–1991): 14 510(k) clearances
- Product codes: JIT (2), JJE (1), CEW (1), KLR (1), CGI (1), CGS (1), DKB (1), CIT (1), LBR (1), DNN (1), KHP (1), CGA (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
- K905146: Olympus Urine PH (Feb 4, 1991)
- K893691: Emds Creatine Kinase Item Nimber 65411 (Aug 31, 1989)
- K893692: Emds Aspartate Aminotransferase Item Number 65405 (Aug 21, 1989)
- K893966: HDL Precipitating Reagent (Jul 25, 1989)
- K884993: Visual Blood Glucose Test System (Dec 29, 1988)
- K881116: Easy-Test Emit (R) Lidocaine Lido Item NO. 16641 (Jun 20, 1988)
- K880787: Easy-Test Lactic Acid (LA) (Mar 15, 1988)
- K862403: Emds Antiepileptic Drug Calibrators Item #67630/95 (Jul 11, 1986)

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