Medical Device Manufacturer · US , Mchenry , IL

Dako Corp. - FDA 510(k) Cleared Devices

54 submissions · 54 cleared · Since 1981
54
Total
54
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dako Corp. Hematology
15 devices
1-15 of 15
Cleared Jun 21, 1999
DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE...
K991402 · GKZ
Hematology · 60d
Cleared Jun 21, 1999
MOUSE IGG1 NEGATIVE CONTROLS
K991454 · GKZ
Hematology · 56d
Cleared Jul 22, 1998
DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37
K980635 · GKZ
Hematology · 153d
Cleared Jun 24, 1997
MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14,...
K964974 · GKZ
Hematology · 194d
Cleared Jul 16, 1996
MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL, (HELPER/INDUCER) RPE
K961701 · GKZ
Hematology · 75d
Cleared Jun 14, 1996
MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE
K960531 · GKZ
Hematology · 128d
Cleared Jun 14, 1996
MOUSE ANTI-HUMAN CD2, T-CELL/FITC AND MOUSE ANTI-HUMAN CD19, B-CELL/RPE
K961435 · GKZ
Hematology · 60d
Cleared May 17, 1996
MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL,...
K960887 · GKZ
Hematology · 74d
Cleared Mar 28, 1996
MOUSE ANTI-HUMAN CD3, T-CELL, FITC & CD8, T-CELL(SUPPRESSOR/CYTOTOXIC) RPE
K955909 · GKZ
Hematology · 90d
Cleared Jan 26, 1996
MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED,...
K945212 · GKZ
Hematology · 458d
Cleared Jan 25, 1995
MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD2, CLONE MT910 FITC-CONJUGATED,...
K945692 · GKZ
Hematology · 65d
Cleared Nov 21, 1994
MONOCLONAL MOUSE ANTI-HUMAN B-CELL
K943284 · GKZ
Hematology · 137d
Cleared Nov 21, 1994
MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25
K944253 · GKZ
Hematology · 82d
Cleared Nov 10, 1994
MONOCLONAL MOUSE ANTI-HUMAN T-CELL
K942797 · GKZ
Hematology · 148d
Cleared Aug 27, 1990
MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT
K896918 · DEH
Hematology · 259d
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