Dako Corp.
Carpinteria, CA, US
Dako Corp. appears in FDA device records in Carpinteria, CA. FDA records list 25 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 25
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 25 510(k) clearances for Dako Corp. between 1990 and 2002. The busiest year on record is 1996, with 7. The most recent is 2002, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 1991 | 1 |
| 1994 | 6 |
| 1995 | 2 |
| 1996 | 7 |
| 1997 | 3 |
| 1998 | 1 |
| 1999 | 2 |
| 2000 | 1 |
| 2002 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K020023 | DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING | MXZ | Substantially Equivalent | |
| K993957 | DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR | MYA | Substantially Equivalent | |
| K991454 | MOUSE IGG1 NEGATIVE CONTROLS | GKZ | Substantially Equivalent | |
| K991402 | DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1 | GKZ | Substantially Equivalent | |
| K980635 | DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37 | GKZ | Substantially Equivalent | |
| K971905 | DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING | DEH | Substantially Equivalent | |
| K965022 | MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751) | DEH | Substantially Equivalent | |
| K964974 | MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPE | GKZ | Substantially Equivalent | |
| K961701 | MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL, (HELPER/INDUCER) RPE | GKZ | Substantially Equivalent | |
| K951965 | DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION | DEH | Substantially Equivalent | |
| K961435 | MOUSE ANTI-HUMAN CD2, T-CELL/FITC AND MOUSE ANTI-HUMAN CD19, B-CELL/RPE | GKZ | Substantially Equivalent | |
| K960531 | MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE | GKZ | Substantially Equivalent | |
| K960887 | MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPE | GKZ | Substantially Equivalent | |
| K955909 | MOUSE ANTI-HUMAN CD3, T-CELL, FITC & CD8, T-CELL(SUPPRESSOR/CYTOTOXIC) RPE | GKZ | Substantially Equivalent | |
| K945212 | MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/ | GKZ | Substantially Equivalent | |
| K931192 | DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODY | DEH | Substantially Equivalent | |
| K945692 | MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD2, CLONE MT910 FITC-CONJUGATED, (ANTI-CD2,FITC, MT910) | GKZ | Substantially Equivalent | |
| K944253 | MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25 | GKZ | Substantially Equivalent | |
| K943284 | MONOCLONAL MOUSE ANTI-HUMAN B-CELL | GKZ | Substantially Equivalent | |
| K924804 | DAKO MOUSE ANTI-HUMAN T-CELL | DEH | Substantially Equivalent | |
| K942797 | MONOCLONAL MOUSE ANTI-HUMAN T-CELL | GKZ | Substantially Equivalent | |
| K932136 | DAKO MOUSE ANTI-HUMAN MELANOMA (DAKO ANTI-HMB45) | DEH | Substantially Equivalent | |
| K924726 | DAKO MOUSE ANTI-HUMAN B-CELL (DAKO-C020-L26 MONO ANTI | DEH | Substantially Equivalent | |
| K905504 | STAINING SYSTEM FOR PNEUMOCYSTIS CARINII | LYF | Substantially Equivalent | |
| K896918 | MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT | DEH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain