FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody
K Number: K183102
·
Decision Dec 7, 2018
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
12
Applicant Total
3
Review Days
30
Basic Information
- Device Name
- BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody
- K Number
- K183102
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.1860
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Leica Biosystems Newcastle Limited
- Date Received
- November 7, 2018
- Decision Date
- December 7, 2018
- 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
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
CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Leica Biosystems Newcastle Limited
| K Number | Device Name | ||
|---|---|---|---|
| K183100 | Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra | Dec 7, 2018 | Substantially Equivalent |
| K171753 | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 | Jul 21, 2017 | Substantially Equivalent |