The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Xt Chemistry Products Urea-crea Slides.
Device ID | K190326 |
510k Number | K190326 |
Device Name: | VITROS XT Chemistry Products UREA-CREA Slides |
Classification | Urease, Photometric, Urea Nitrogen |
Applicant | Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626 |
Contact | Darlene Phillips |
Correspondent | Darlene Phillips Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626 |
Product Code | CDN |
CFR Regulation Number | 862.1770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-02-13 |
Decision Date | 2019-03-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10758750031788 | K190326 | 000 |