# Harleco

- Location (FDA's records): Mchenry, IL
- FDA decisions: 116 (1976–1982): 116 510(k) clearances
- Product codes: CGX (8), CGS (6), CIG (6), CEK (6), CFR (6), CEO (5), CJE (5), CIX (5), CJY (4), CFJ (4), CKA (4), JMK (4)
- 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
- K820233: Ultrazyme Plus Gamma GT (65055-65056) (Feb 12, 1982)
- K813427: Ultrachem Gluc-DH (Dec 31, 1981)
- K813043: Ultrachem Crea Item #64972 (Nov 10, 1981)
- K813038: Ultrachem TP, Item #64974 (Nov 10, 1981)
- K813042: Ultrachem Gluc-DH Set, Item #65048 (Nov 10, 1981)
- K813041: Ultrazyme-GT, Item #64959 & 65032 (Nov 10, 1981)
- K813044: Ultrachem Alb, Item #64970 (Nov 10, 1981)
- K813039: Ultrachem E-Chol, Item #65025 (Nov 10, 1981)

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