# Ortho Instruments

- Location (FDA's records): Mchenry, IL
- FDA decisions: 6 (1978–1980): 6 510(k) clearances
- Product codes: GKL (3), JPK (3)
- 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
- K803073: Ortho Hematology Control (Dec 31, 1980)
- K803083: Ortho Hemotology Control-Normal (Dec 31, 1980)
- K803084: Ortho Hematology Control Abnormal Low (Dec 31, 1980)
- K802094: Ortho Spectrum (Oct 10, 1980)
- K801545: Ortho Automated Cell Counter (Sep 9, 1980)
- K781146: Hemac Laser Hematology System (Sep 14, 1978)

Source page: https://510kreport.com/company/ortho-instruments