FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING
K Number: K020023
·
Decision Feb 28, 2002
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
12
Applicant Total
54
Review Days
56
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Basic Information
- Device Name
- DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING
- K Number
- K020023
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.1860
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dako Corp.
- Date Received
- January 3, 2002
- Decision Date
- February 28, 2002
- Product Code
- MXZ
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MXZ | Immunohistochemistry Assay, Antibody, Progesterone Receptor | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MXZ), ordered by most recent decision date.
BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).
FDA 510(k)
FDA Class 2
·Hematology
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody
FDA 510(k)
FDA Class 2
·Hematology
FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)
FDA 510(k)
FDA Class 2
·Hematology
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16
FDA 510(k)
FDA Class 2
·Hematology
FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link)
FDA 510(k)
FDA Class 2
·Hematology
MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Dako Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K993957 | DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR | Mar 3, 2000 | Substantially Equivalent |
| K991402 | DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1 | Jun 21, 1999 | Substantially Equivalent |
| K991454 | MOUSE IGG1 NEGATIVE CONTROLS | Jun 21, 1999 | Substantially Equivalent |
| K980635 | DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37 | Jul 22, 1998 | Substantially Equivalent |
| K971905 | DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING | Dec 12, 1997 | Substantially Equivalent |
| K965022 | MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751) | Nov 6, 1997 | Substantially Equivalent |
| K964974 | MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPE | Jun 24, 1997 | Substantially Equivalent |
| K961701 | MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL, (HELPER/INDUCER) RPE | Jul 16, 1996 | Substantially Equivalent |
| K951965 | DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION | Jul 5, 1996 | Substantially Equivalent |
| K960531 | MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE | Jun 14, 1996 | Substantially Equivalent |