The following data is part of a premarket notification filed by Ortho Clinical Diagnostics with the FDA for Vitros Brahms Pct Reagent Pack And Calibrators.
| Device ID | K200236 |
| 510k Number | K200236 |
| Device Name: | VITROS BRAHMS PCT Reagent Pack And Calibrators |
| Classification | Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens |
| Applicant | Ortho Clinical Diagnostics 100 Indigo Creek Drive Rochester, NY 14626 |
| Contact | Ann M Quinn |
| Correspondent | Ann M Quinn Ortho Clinical Diagnostics 100 Indigo Creek Drive Rochester, NY 14626 |
| Product Code | PMT |
| CFR Regulation Number | 866.3215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-30 |
| Decision Date | 2020-02-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750033294 | K200236 | 000 |
| 10758750033287 | K200236 | 000 |