FDA Product Code
FDA Product Code MXZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.1860
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K193393 | BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). | Leica Biosystems Newcastle, Ltd. | 2020-03-06 | Traditional | PDF ↗ |
| K183102 | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody | Leica Biosystems Newcastle, Limited | 2018-12-07 | Special | PDF ↗ |
| K170005 | FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) | Dako Denmark A/S | 2017-12-21 | Traditional | PDF ↗ |
| K171753 | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 | Leica Biosystems Newcastle, Limited | 2017-07-21 | Special | PDF ↗ |
| K160922 | 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) | Dako North America, Inc. | 2016-05-03 | Special | PDF ↗ |
| K130861 | MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK) | Dako North America, Inc. | 2013-12-09 | Traditional | PDF ↗ |
| K103818 | CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY | Ventana Medical Sytems, Inc. | 2011-11-16 | Traditional | PDF ↗ |
| K062615 | VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16 | Vision Biosystems, Inc. | 2007-01-29 | Abbreviated | PDF ↗ |
| K060462 | NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2) | Lab Vision Corp. | 2006-04-24 | Traditional | PDF ↗ |
| K042884 | DAKOCYTOMATION ER/PR PHARMDX KIT | Dakocytomation California, Inc. | 2005-02-15 | Traditional | PDF ↗ |
| K012960 | BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR | Biogenex Laboratories | 2002-03-08 | Traditional | PDF ↗ |
| K020023 | DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING | Dako Corp. | 2002-02-28 | Traditional | PDF ↗ |
| K990618 | VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6) | Ventana Medical Systems, Inc. | 1999-07-23 | Traditional | PDF ↗ |
Product code MXZ · Class II · Hematology. Data: openFDA.