# Dako Corp.

- Location (FDA's records): Carpinteria, CA
- FDA decisions: 54 (1981–2002): 54 510(k) clearances
- Product codes: GKZ (14), DEH (9), DEW (4), CZW (3), DFH (2), CZP (2), DBI (2), DDG (1), LYF (1), DEB (1), MYA (1), DDZ (1)
- Predicates its devices cite: 10 (7 its own); citations of its devices by later devices: 16 (7 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Abbott Laboratories: 2 (https://510kreport.com/company/abbott-laboratories)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 1 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)

## Firms that cite its devices most
- Dakocytomation California, Inc.: 5 (https://510kreport.com/company/dakocytomation-california)
- Ventana Medical Systems, Inc.: 1 (https://510kreport.com/company/ventana-medical-systems)
- Roche Diagnostics Corp.: 1 (https://510kreport.com/company/roche-diagnostics)
- Biogenex Laboratories: 1 (https://510kreport.com/company/biogenex-laboratories)
- Ventana Medical Sytems, Inc.: 1 (https://510kreport.com/company/ventana-medical-sytems)

## Its most-cited devices
- K993957: Dako Monoclonal Mouse Anti-Human Estrogen Receptor (2000), cited by 2
- K020023: Dako Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Antibody for Immunoenzymatic Staining (2002), cited by 2
- K943284: Monoclonal Mouse Anti-Human B-Cell (1994), cited by 1
- K944253: Monoclonal Mouse Anti-Human T-Cell, CD8, Rpe-Conjugated, Clone DK25 (1994), cited by 1
- K942797: Monoclonal Mouse Anti-Human T-Cell (1994), cited by 1
- K955909: Mouse Anti-Human CD3, T-Cell, Fitc & CD8, T-Cell (Suppressor/Cytotoxic) Rpe (1996), cited by 1

## Recent decisions
- K020023: Dako Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Antibody for Immunoenzymatic Staining (Feb 28, 2002)
- K993957: Dako Monoclonal Mouse Anti-Human Estrogen Receptor (Mar 3, 2000)
- K991454: Mouse IGG1 Negative Controls (Jun 21, 1999)
- K991402: Dako Mouse Anti-Human T-Cell, CD3/Rpe-CY5, Clone UCHT1 & Dako Mouse Anti-Human T-Cell, CD3/Rpe, Clone UCHT1 (Jun 21, 1999)
- K980635: Dako Mouse Anti-Human B-Cell, CD19/Rpe-CY5, Clone HD37 (Jul 22, 1998)
- K971905: Dako Mouse Anti Human Cytokeratin, High Molecular Weight, Clone 34BE12, Monoclonal Antibody for Immunoenzymatic Staining (Dec 12, 1997)
- K965022: Monoclonal Mouse Anti-Human CD30, KI-1 Antigen, Ber-H2 Antibody for Immunoenzymatic Staining (Product Code NO. MO751) (Nov 6, 1997)
- K964974: Mouse Anti-Human CD45, Leucocyte Common Antigen (Lca)/Fitc and CD14, Monocyte/Rpe (Jun 24, 1997)

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