K183102 is an FDA 510(k) clearance for the BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody. This device is classified as a Immunohistochemistry Assay, Antibody, Progesterone Receptor (Class II - Special Controls, product code MXZ).
Submitted by Leica Biosystems Newcastle, Limited (Newcastle Upon Tyne, GB). The FDA issued a Cleared decision on December 7, 2018, 30 days after receiving the submission on November 7, 2018.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.1860.
| 510(k) Number | K183102 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 2018 |
| Decision Date | December 07, 2018 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Pathology (PA) |
| Summary | Statement |
| Product Code | MXZ — Immunohistochemistry Assay, Antibody, Progesterone Receptor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.1860 |