# Harleco Diagnostics

- Location (FDA's records): Mchenry, IL
- FDA decisions: 23 (1976–1982): 23 510(k) clearances
- Product codes: CGS (2), CIX (2), CFJ (2), LFR (1), CDO (1), JPZ (1), JFJ (1), CEO (1), CIT (1), JMK (1), CKA (1), CDT (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
- K823147: Uric Acid Standard, 8MG/DL #65078 (Nov 22, 1982)
- K822852: Triglyceride Calibrator (Oct 27, 1982)
- K822323: Ultrachem Bun-UV, 65080 & 65081 (Sep 2, 1982)
- K821883: Ultrazyme Plus CK-I (Jul 14, 1982)
- K821872: Ultrachem Uric Acid Aidh (Jul 14, 1982)
- K821871: Ultrazyme Plus 2GT (Jul 14, 1982)
- K821877: Ultrazyme Plus HBD (Jul 14, 1982)
- K821882: Ultrazyme Plus GPT (Jul 14, 1982)

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