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 |