The following data is part of a premarket notification filed by Ortho Clinical Diagnostics with the FDA for Vitros Immunodiagnostic Products Nt-probnp Ii Reagent Pack.
| Device ID | K201312 |
| 510k Number | K201312 |
| Device Name: | VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack |
| Classification | Test, Natriuretic Peptide |
| Applicant | Ortho Clinical Diagnostics 100 Indigo Creek Drive Rochester, NY 14626 |
| Contact | Leah Van De Water |
| Correspondent | Ann Quinn Ortho Clinical Diagnostics 100 Indigo Creek Drive Rochester, NY 14626 |
| Product Code | NBC |
| CFR Regulation Number | 862.1117 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-18 |
| Decision Date | 2021-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750033300 | K201312 | 000 |