# Ortho Diagnostics, Inc.

- Location (FDA's records): Mchenry, IL
- FDA decisions: 24 (1977–1980): 24 510(k) clearances
- Product codes: KSG (2), JPK (2), JBQ (2), KSF (2), KSX (2), JHJ (2), JJS (1), GFO (1), LAS (1), CDX (1), CDP (1), GOL (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
- K802404: Ortho Bovine Albumin Solution 30% Prote (Oct 23, 1980)
- K801507: Antigen Control Cells (Aug 20, 1980)
- K800357: BI-Level Assayed Card. Drug Cont., I,II (Apr 16, 1980)
- K800310: Ortho Antisera Control (Mar 5, 1980)
- K791791: Ortho Antibody Enhancement Solution (Oct 11, 1979)
- K791301: Ortho TSH Ria Kit (Sep 24, 1979)
- K790813: Multecon Blood Gas Control (Jun 28, 1979)
- K782166: Slide Test for Pregnancy, Gravindex 90 (Apr 4, 1979)

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