FDA 510(k) Applications Submitted by DAKO CORP.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K965022 |
12/16/1996 |
MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751) |
DAKO CORP. |
| K945212 |
10/25/1994 |
MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/ |
DAKO CORP. |
| K020023 |
01/03/2002 |
DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING |
DAKO CORP. |
| K960531 |
02/07/1996 |
MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE |
DAKO CORP. |
| K960887 |
03/04/1996 |
MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPE |
DAKO CORP. |
| K991402 |
04/22/1999 |
DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1 |
DAKO CORP. |
| K991454 |
04/26/1999 |
MOUSE IGG1 NEGATIVE CONTROLS |
DAKO CORP. |
| K971905 |
05/23/1997 |
DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING |
DAKO CORP. |
| K993957 |
11/22/1999 |
DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR |
DAKO CORP. |
| K955909 |
12/29/1995 |
MOUSE ANTI-HUMAN CD3, T-CELL, FITC & CD8, T-CELL(SUPPRESSOR/CYTOTOXIC) RPE |
DAKO CORP. |
| K980635 |
02/19/1998 |
DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37 |
DAKO CORP. |
| K961435 |
04/15/1996 |
MOUSE ANTI-HUMAN CD2, T-CELL/FITC AND MOUSE ANTI-HUMAN CD19, B-CELL/RPE |
DAKO CORP. |
| K961701 |
05/02/1996 |
MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL, (HELPER/INDUCER) RPE |
DAKO CORP. |
| K964974 |
12/12/1996 |
MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPE |
DAKO CORP. |
| K951965 |
04/27/1995 |
DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION |
DAKO CORP. |
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