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Dako Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
56
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K041627CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATORSeptember 3, 2004
K032692DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368January 22, 2004
K020023DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC February 28, 2002
K993957DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTORMarch 3, 2000
K991402DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONJune 21, 1999
K991454MOUSE IGG1 NEGATIVE CONTROLSJune 21, 1999
K980635DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37July 22, 1998
K971905DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUDecember 12, 1997
K965022MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCNovember 6, 1997
K964974MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPEJune 24, 1997
K961701MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL, (HELPER/INDUCER) RPEJuly 16, 1996
K951965DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISIONJuly 5, 1996
K961435MOUSE ANTI-HUMAN CD2, T-CELL/FITC AND MOUSE ANTI-HUMAN CD19, B-CELL/RPEJune 14, 1996
K960531MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPEJune 14, 1996
K960887MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPEMay 17, 1996
K955909MOUSE ANTI-HUMAN CD3, T-CELL, FITC & CD8, T-CELL(SUPPRESSOR/CYTOTOXIC) RPEMarch 28, 1996
K945212MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-COJanuary 26, 1996
K931192DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODYApril 20, 1995
K945692MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD2, CLONE MT910 FITC-CONJUGATED, (ANTI-CD2,FITC, MT910)January 25, 1995
K943284MONOCLONAL MOUSE ANTI-HUMAN B-CELLNovember 21, 1994