K193393 is an FDA 510(k) clearance for the BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).. This device is classified as a Immunohistochemistry Assay, Antibody, Progesterone Receptor (Class II - Special Controls, product code MXZ).
Submitted by Leica Biosystems Newcastle, Ltd. (Newcastle Upon Tyne, GB). The FDA issued a Cleared decision on March 6, 2020, 91 days after receiving the submission on December 6, 2019.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.1860.
| 510(k) Number | K193393 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2019 |
| Decision Date | March 06, 2020 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| Product Code | MXZ - Immunohistochemistry Assay, Antibody, Progesterone Receptor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.1860 |