The following data is part of a premarket notification filed by Meso Scale Diagnostics, Llc with the FDA for Msd Crp Assay Kit And Meso Sector S 700 Instrument.
| Device ID | K171498 |
| 510k Number | K171498 |
| Device Name: | MSD CRP Assay Kit And MESO SECTOR S 700 Instrument |
| Classification | System, Test, C-reactive Protein |
| Applicant | Meso Scale Diagnostics, LLC 1601 Research Boulevard Rockville, MD 20850 |
| Contact | Lillian Quintero |
| Correspondent | Lillian Quintero Meso Scale Diagnostics, LLC 1601 Research Boulevard Rockville, MD 20850 |
| Product Code | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-23 |
| Decision Date | 2018-01-12 |
| Summary: | summary |