Company ยท US
Dako Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2002. Name variants (Inc, Corp, punctuation) are merged.
54510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GKZ | Counter, Differential Cell | 14 |
| DEH | Lambda, Antigen, Antiserum, Control | 9 |
| DEW | Igg, Antigen, Antiserum, Control | 4 |
| CZW | Complement C3, Antigen, Antiserum, Control | 3 |
| CZP | Iga, Antigen, Antiserum, Control | 2 |
| DBI | Complement C4, Antigen, Antiserum, Control | 2 |
| DFH | Kappa, Antigen, Antiserum, Control | 2 |
| CZN | Iga, Fitc, Antigen, Antiserum, Control | 1 |
| DAD | Haptoglobin, Antigen, Antiserum, Control | 1 |
| DAH | Gamma Globulin, Antigen, Antiserum, Control | 1 |
| DAO | Igm (Mu Chain Specific), Antigen, Antiserum, Control | 1 |
| DCF | Albumin, Antigen, Antiserum, Control | 1 |
| DDB | Ceruloplasmin, Antigen, Antiserum, Control | 1 |
| DDG | Transferrin, Antigen, Antiserum, Control | 1 |
| DDZ | Albumin, Fitc, Antigen, Antiserum, Control | 1 |
| DEB | Alpha-2-Macroglobulin, Antigen, Antiserum, Control | 1 |
| DEO | Kappa, Fitc, Antigen, Antiserum, Control | 1 |
| DES | Lambda, Fitc, Antigen, Antiserum, Control | 1 |
| DFS | Igm, Fitc, Antigen, Antiserum, Control | 1 |
| DGK | Igg, Fitc, Antigen, Antiserum, Control | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 28, 2002 | K020023 | DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING Dako Corp. | MXZ |
| Mar 3, 2000 | K993957 | DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR Dako Corp. | MYA |
| Jun 21, 1999 | K991454 | MOUSE IGG1 NEGATIVE CONTROLS Dako Corp. | GKZ |
| 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 Dako Corp. | GKZ |
| Jul 22, 1998 | K980635 | DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37 Dako Corp. | GKZ |
| Dec 12, 1997 | K971905 | DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING Dako Corp. | DEH |
| Nov 6, 1997 | K965022 | MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751) Dako Corp. | DEH |
| Jun 24, 1997 | K964974 | MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPE Dako Corp. | GKZ |
| Jul 16, 1996 | K961701 | MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL, (HELPER/INDUCER) RPE Dako Corp. | GKZ |
| Jul 5, 1996 | K951965 | DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION Dako Corp. | DEH |
| Jun 14, 1996 | K961435 | MOUSE ANTI-HUMAN CD2, T-CELL/FITC AND MOUSE ANTI-HUMAN CD19, B-CELL/RPE Dako Corp. | GKZ |
| Jun 14, 1996 | K960531 | MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE Dako Corp. | GKZ |
| May 17, 1996 | K960887 | MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPE Dako Corp. | GKZ |
| Mar 28, 1996 | K955909 | MOUSE ANTI-HUMAN CD3, T-CELL, FITC & CD8, T-CELL(SUPPRESSOR/CYTOTOXIC) RPE Dako Corp. | GKZ |
| Jan 26, 1996 | K945212 | MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/ Dako Corp. | GKZ |
| Apr 20, 1995 | K931192 | DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODY Dako Corp. | DEH |
| Jan 25, 1995 | K945692 | MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD2, CLONE MT910 FITC-CONJUGATED, (ANTI-CD2,FITC, MT910) Dako Corp. | GKZ |
| Nov 21, 1994 | K944253 | MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25 Dako Corp. | GKZ |
| Nov 21, 1994 | K943284 | MONOCLONAL MOUSE ANTI-HUMAN B-CELL Dako Corp. | GKZ |
| Nov 21, 1994 | K924804 | DAKO MOUSE ANTI-HUMAN T-CELL Dako Corp. | DEH |
| Nov 10, 1994 | K942797 | MONOCLONAL MOUSE ANTI-HUMAN T-CELL Dako Corp. | GKZ |
| Jun 13, 1994 | K932136 | DAKO MOUSE ANTI-HUMAN MELANOMA (DAKO ANTI-HMB45) Dako Corp. | DEH |
| Jun 13, 1994 | K924726 | DAKO MOUSE ANTI-HUMAN B-CELL (DAKO-C020-L26 MONO ANTI Dako Corp. | DEH |
| Feb 14, 1992 | K912666 | DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440 Dako Corp., DK | LIQ |
| Jun 28, 1991 | K905504 | STAINING SYSTEM FOR PNEUMOCYSTIS CARINII Dako Corp. | LYF |
| Aug 27, 1990 | K896918 | MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT Dako Corp. | DEH |
| Apr 21, 1987 | K871346 | DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY Dako Corp. | CZW |
| Aug 25, 1986 | K861059 | DAKO ITA SYSTEM Dako Corp. | DEW |
| Aug 19, 1986 | K862184 | DAKO ITA, IMMUNOGLOBULIN M (IGM) Dako Corp. | DAH |
| Aug 19, 1986 | K862183 | DAKO ITA, IMMUNOGLOBULIN A (IGA) Dako Corp. | CZP |
| Jul 19, 1983 | K831907 | RABBIT ANTISERUM TO HUMAN IGM Dako Corp. | DFS |
| Jul 19, 1983 | K831906 | RABBIT ANTISERUM TO HUMAN C4 Dako Corp. | DBI |
| Jul 19, 1983 | K831904 | RABBIT ANTISERUM TO HUMAN KAPPA LIGHT Dako Corp. | DEO |
| Jul 19, 1983 | K831903 | FLUORESCEIN CONJUGATED IMMUNOGLOBULIN Dako Corp. | DES |
| Jul 18, 1983 | K831909 | RABBIT ANTISERUM TO HUMAN IGA Dako Corp. | CZN |
| Jul 18, 1983 | K831908 | RABBIT ANTISERUM TO HUMAN IGG Dako Corp. | DGK |
| Jul 18, 1983 | K831905 | RABBITT ANTISERUM TO HUMAN C3C Dako Corp. | CZW |
| Jul 18, 1983 | K831902 | FLUORESCEIN CONJUGATED IMMUNOGLOBIN- Dako Corp. | DDZ |
| Jul 13, 1982 | K820336 | DAKO PAP KIT K509 Dako Corp. | LIJ |
| Feb 10, 1982 | K812485 | DAKO PAP KIT K504 Dako Corp. | DFH |
| Feb 10, 1982 | K812484 | DAKO PAP KIT K505 Dako Corp. | DEW |
| Sep 29, 1981 | K812662 | IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDA Dako Corp. | DEH |
| Sep 29, 1981 | K812661 | IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPA Dako Corp. | DFH |
| Sep 23, 1981 | K812496 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALBUM Dako Corp. | DCF |
| Sep 23, 1981 | K812495 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALPHA Dako Corp. | DEW |
| Sep 23, 1981 | K812494 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-HAPTO Dako Corp. | DAD |
| Sep 23, 1981 | K812493 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-MACRO Dako Corp. | DEB |
| Sep 23, 1981 | K812492 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-TRAN Dako Corp. | DDG |
| Sep 23, 1981 | K812491 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-C3 Dako Corp. | CZW |
| Sep 23, 1981 | K812490 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-C4 Dako Corp. | DBI |
Newest 50 of 54.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||