The following data is part of a premarket notification filed by Roche Diagnostics Operations (rdo) with the FDA for Tina-quant C-reactive Protein Iv.
| Device ID | K192072 |
| 510k Number | K192072 |
| Device Name: | Tina-quant C-Reactive Protein IV |
| Classification | System, Test, C-reactive Protein |
| Applicant | Roche Diagnostics Operations (RDO) 9115 Hague Rd Indianapolis, IN 46250 |
| Contact | Barbara Ann Mcwhorter |
| Correspondent | Barbara Ann Mcwhorter Roche Diagnostics Operations (RDO) 9115 Hague Rd Indianapolis, IN 46250 |
| Product Code | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-02 |
| Decision Date | 2020-02-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630946853 | K192072 | 000 |
| 04015630946846 | K192072 | 000 |
| 04015630946839 | K192072 | 000 |
| 07613336121191 | K192072 | 000 |