Dako Corp.
Medical device manufacturer in Carpinteria, CA.
54510(k) clearances
0PMA approvals
0recalls
Device types
- GKZ Counter, Differential Cell 14
- DEH Lambda, Antigen, Antiserum, Control 9
- DEW Igg, Antigen, Antiserum, Control 4
- CZW Complement C3, Antigen, Antiserum, Control 3
- DFH Kappa, Antigen, Antiserum, Control 2
- DBI Complement C4, Antigen, Antiserum, Control 2
- CZP Iga, Antigen, Antiserum, Control 2
- DDG Transferrin, Antigen, Antiserum, Control 1
- DEB Alpha-2-Macroglobulin, Antigen, Antiserum… 1
- DAD Haptoglobin, Antigen, Antiserum, Control 1
- DCF Albumin, Antigen, Antiserum, Control 1
- DDB Ceruloplasmin, Antigen, Antiserum, Control 1
- LIJ Peroxidase Anti-Peroxidase Immunohistochemic… 1
- DDZ Albumin, Fitc, Antigen, Antiserum, Control 1
- DGK Igg, Fitc, Antigen, Antiserum, Control 1
- CZN Iga, Fitc, Antigen, Antiserum, Control 1
- DES Lambda, Fitc, Antigen, Antiserum, Control 1
- DEO Kappa, Fitc, Antigen, Antiserum, Control 1
- DFS Igm, Fitc, Antigen, Antiserum, Control 1
- MXZ Immunohistochemistry Assay, Antibody… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K020023 | Dako Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PGR 636, Antibody for…MXZ · Traditional | 02/28/2002SE |
| K993957 | Dako Monoclonal Mouse Anti-Human Estrogen ReceptorMYA · Traditional | 03/03/2000SE |
| K991454 | Mouse IGG1 Negative ControlsGKZ · Traditional | 06/21/1999SE |
| K991402 | Dako Mouse Anti-Human T-Cell, CD3/RPE-CY5, Clone UCHT1 & Dako Mouse Anti-Human T-Cell…GKZ · Traditional | 06/21/1999SE |
| K980635 | Dako Mouse Anti-Human B-Cell, CD19/RPE-CY5, Clone HD37GKZ · Traditional | 07/22/1998SE |
| K971905 | Dako Mouse Anti Human Cytokeratin, High Molecular Weight, Clone 34BE12, Monoclonal…DEH · Traditional | 12/12/1997SE |
| K965022 | Monoclonal Mouse Anti-Human CD30, KI-1 Antigen, BER-H2 Antibody for Immunoenzymatic…DEH · Traditional | 11/06/1997SE |
| K964974 | Mouse Anti-Human CD45, Leucocyte Common Antigen (Lca)/Fitc and CD14, Monocyte/RpeGKZ · Traditional | 06/24/1997SE |
| K961701 | Mouse Anti-Human CD3, T-Cell, Fitc and CD4, T-Cell, (Helper/Inducer) RpeGKZ · Traditional | 07/16/1996SE |
| K951965 | Dako Labeled Streptavidin-Biotin 2 Kit, and EnvisionDEH · Traditional | 07/05/1996SE |
| K961435 | Mouse Anti-Human CD2, T-Cell/Fitc and Mouse Anti-Human CD19, B-Cell/RpeGKZ · Traditional | 06/14/1996SE |
| K960531 | Mouse Anti-Human CD3, T-Cell/Fitc & CD19, B-Cell/RpeGKZ · Traditional | 06/14/1996SE |
| K960887 | Mouse Anti-Human CD4, T-Cell, Helper/Inducer/Fitc & CD8, T-Cell, Suppressor/Cytotoxic/RpeGKZ · Traditional | 05/17/1996SE |
| K955909 | Mouse Anti-Human CD3, T-Cell, Fitc & CD8, T-Cell(Suppressor/Cytotoxic) RpeGKZ · Traditional | 03/28/1996SE |
| K945212 | Monoclonal Mouse Anti-Human T-Cell, CD4, Clone MT310, Fitc-Conjugated, (ANTI-CD4/FITC…GKZ · Traditional | 01/26/1996SE |
| K931192 | Dako Rabbit Anti-Cow S-100 Polyclonal AntibodyDEH · Traditional | 04/20/1995SE |
| K945692 | Monoclonal Mouse Anti-Human T-Cell, CD2, Clone MT910 Fitc-Conjugated, (ANTI-CD2,FITC…GKZ · Traditional | 01/25/1995SE |
| K944253 | Monoclonal Mouse Anti-Human T-Cell, CD8, Rpe-Conjugated, Clone DK25GKZ · Traditional | 11/21/1994SE |
| K943284 | Monoclonal Mouse Anti-Human B-CellGKZ · Traditional | 11/21/1994SE |
| K924804 | Dako Mouse Anti-Human T-CellDEH · Traditional | 11/21/1994SE |
| K942797 | Monoclonal Mouse Anti-Human T-CellGKZ · Traditional | 11/10/1994SE |
| K932136 | Dako Mouse Anti-Human Melanoma (Dako ANTI-HMB45)DEH · Traditional | 06/13/1994SE |
| K924726 | Dako Mouse Anti-Human B-Cell (DAKO-C020-L26 Mono AntiDEH · Traditional | 06/13/1994SE |
| K912666 | Dako Elisa Rotavirus Kit- 96 Tests K440LIQ · Traditional | 02/14/1992SE |
| K905504 | Staining System for Pneumocystis CariniiLYF · Traditional | 06/28/1991SE |
| K896918 | Mouse Anti-Human Leucocyte Antigen & Dako Pap KitDEH · Traditional | 08/27/1990SE |
| K871346 | Dako Ita(Tm) System, for Immunoturbidimetric AssayCZW · Traditional | 04/21/1987SE |
| K861059 | Dako Ita SystemDEW · Traditional | 08/25/1986SE |
| K862184 | Dako Ita, Immunoglobulin M (Igm)DAH · Traditional | 08/19/1986SE |
| K862183 | Dako Ita, Immunoglobulin a (Iga)CZP · Traditional | 08/19/1986SE |
| K831907 | Rabbit Antiserum to Human IgmDFS · Traditional | 07/19/1983SE |
| K831906 | Rabbit Antiserum to Human C4DBI · Traditional | 07/19/1983SE |
| K831904 | Rabbit Antiserum to Human Kappa LightDEO · Traditional | 07/19/1983SE |
| K831903 | Fluorescein Conjugated ImmunoglobulinDES · Traditional | 07/19/1983SE |
| K831909 | Rabbit Antiserum to Human IgaCZN · Traditional | 07/18/1983SE |
| K831908 | Rabbit Antiserum to Human IggDGK · Traditional | 07/18/1983SE |
| K831905 | Rabbitt Antiserum to Human C3CCZW · Traditional | 07/18/1983SE |
| K831902 | Fluorescein Conjugated Immunoglobin-DDZ · Traditional | 07/18/1983SE |
| K820336 | Dako Pap Kit K509LIJ · Traditional | 07/13/1982SE |
| K812485 | Dako Pap Kit K504DFH · Traditional | 02/10/1982SE |
| K812484 | Dako Pap Kit K505DEW · Traditional | 02/10/1982SE |
| K812662 | Immunogl. Fract. of Rabbit Antis./LambdaDEH · Traditional | 09/29/1981SE |
| K812661 | Immunogl. Fract. of Rabbit Antis./KappaDFH · Traditional | 09/29/1981SE |
| K812496 | Immunogl. Frct. of Rabbit Antiser.-AlbumDCF · Traditional | 09/23/1981SE |
| K812495 | Immunogl. Frct. of Rabbit Antiser.-AlphaDEW · Traditional | 09/23/1981SE |
| K812494 | Immunogl. Frct. of Rabbit Antiser.-HaptoDAD · Traditional | 09/23/1981SE |
| K812493 | Immunogl. Frct. of Rabbit Antiser.-MacroDEB · Traditional | 09/23/1981SE |
| K812492 | Immunogl. Frct. of Rabbit Antiser.-TranDDG · Traditional | 09/23/1981SE |
| K812491 | Immunogl. Frct. of Rabbit ANTISER.-C3CZW · Traditional | 09/23/1981SE |
| K812490 | Immunogl. Frct. of Rabbit ANTISER.-C4DBI · Traditional | 09/23/1981SE |
| K812489 | Immunogl. Frct. of Rabbit Antiser.-IggDEW · Traditional | 09/23/1981SE |
| K812488 | Immunogl. Frct. of Rabbit Antiser.-IgaCZP · Traditional | 09/23/1981SE |
| K812487 | Immunogl. Frct. of Rabbit Antiser.-IgmDAO · Traditional | 09/23/1981SE |
| K812486 | Immunogl. Frct. of Rabbit Antiser.-CerulDDB · Traditional | 09/23/1981SE |