Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Dako Corp. — Predicate Candidate Screening

54 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

71 daysmedian FDA review time

406 days90th percentile

54clearances measured

K-number	Device	Applicant	Decided	Review days
K020023	DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLON	Dako Corp.	2002-02-28	56
K993957	DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR	Dako Corp.	2000-03-03	102
K991402	DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAK	Dako Corp.	1999-06-21	60
K991454	MOUSE IGG1 NEGATIVE CONTROLS	Dako Corp.	1999-06-21	56
K980635	DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37	Dako Corp.	1998-07-22	153
K971905	DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CL	Dako Corp.	1997-12-12	203
K965022	MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIB	Dako Corp.	1997-11-06	325
K964974	MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC A	Dako Corp.	1997-06-24	194
K961701	MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL, (HELPER/	Dako Corp.	1996-07-16	75
K951965	DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION	Dako Corp.	1996-07-05	435
K960531	MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE	Dako Corp.	1996-06-14	128
K961435	MOUSE ANTI-HUMAN CD2, T-CELL/FITC AND MOUSE ANTI-HUMAN CD19,	Dako Corp.	1996-06-14	60
K960887	MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-C	Dako Corp.	1996-05-17	74
K955909	MOUSE ANTI-HUMAN CD3, T-CELL, FITC & CD8, T-CELL(SUPPRESSOR/	Dako Corp.	1996-03-28	90
K945212	MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-C	Dako Corp.	1996-01-26	458
K931192	DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODY	Dako Corp.	1995-04-20	772
K945692	MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD2, CLONE MT910 FITC-CO	Dako Corp.	1995-01-25	65
K924804	DAKO MOUSE ANTI-HUMAN T-CELL	Dako Corp.	1994-11-21	788
K943284	MONOCLONAL MOUSE ANTI-HUMAN B-CELL	Dako Corp.	1994-11-21	137
K944253	MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLO	Dako Corp.	1994-11-21	82
K942797	MONOCLONAL MOUSE ANTI-HUMAN T-CELL	Dako Corp.	1994-11-10	148
K924726	DAKO MOUSE ANTI-HUMAN B-CELL (DAKO-C020-L26 MONO ANTI	Dako Corp.	1994-06-13	630
K932136	DAKO MOUSE ANTI-HUMAN MELANOMA (DAKO ANTI-HMB45)	Dako Corp.	1994-06-13	406
K912666	DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440	Dako Corp.	1992-02-14	241
K905504	STAINING SYSTEM FOR PNEUMOCYSTIS CARINII	Dako Corp.	1991-06-28	203
K896918	MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT	Dako Corp.	1990-08-27	259
K871346	DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY	Dako Corp.	1987-04-21	15
K861059	DAKO ITA SYSTEM	Dako Corp.	1986-08-25	159
K862184	DAKO ITA, IMMUNOGLOBULIN M (IGM)	Dako Corp.	1986-08-19	71
K862183	DAKO ITA, IMMUNOGLOBULIN A (IGA)	Dako Corp.	1986-08-19	71
K831906	RABBIT ANTISERUM TO HUMAN C4	Dako Corp.	1983-07-19	35
K831903	FLUORESCEIN CONJUGATED IMMUNOGLOBULIN	Dako Corp.	1983-07-19	35
K831907	RABBIT ANTISERUM TO HUMAN IGM	Dako Corp.	1983-07-19	35
K831904	RABBIT ANTISERUM TO HUMAN KAPPA LIGHT	Dako Corp.	1983-07-19	35
K831902	FLUORESCEIN CONJUGATED IMMUNOGLOBIN-	Dako Corp.	1983-07-18	34
K831909	RABBIT ANTISERUM TO HUMAN IGA	Dako Corp.	1983-07-18	34
K831905	RABBITT ANTISERUM TO HUMAN C3C	Dako Corp.	1983-07-18	34
K831908	RABBIT ANTISERUM TO HUMAN IGG	Dako Corp.	1983-07-18	34
K820336	DAKO PAP KIT K509	Dako Corp.	1982-07-13	155
K812484	DAKO PAP KIT K505	Dako Corp.	1982-02-10	163
K812485	DAKO PAP KIT K504	Dako Corp.	1982-02-10	163
K812661	IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPA	Dako Corp.	1981-09-29	11
K812662	IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDA	Dako Corp.	1981-09-29	11
K812487	IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM	Dako Corp.	1981-09-23	23
K812493	IMMUNOGL. FRCT. OF RABBIT ANTISER.-MACRO	Dako Corp.	1981-09-23	23
K812489	IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGG	Dako Corp.	1981-09-23	23
K812490	IMMUNOGL. FRCT. OF RABBIT ANTISER.-C4	Dako Corp.	1981-09-23	23
K812492	IMMUNOGL. FRCT. OF RABBIT ANTISER.-TRAN	Dako Corp.	1981-09-23	23
K812488	IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA	Dako Corp.	1981-09-23	23
K812486	IMMUNOGL. FRCT. OF RABBIT ANTISER.-CERUL	Dako Corp.	1981-09-23	23

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda