The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Xt Chemistry Products Trig-chol Slides.
Device ID | K190490 |
510k Number | K190490 |
Device Name: | VITROS XT Chemistry Products TRIG-CHOL Slides |
Classification | Enzymatic Esterase--oxidase, Cholesterol |
Applicant | Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626 |
Contact | Alexandra Chamberlain |
Correspondent | Alexandra Chamberlain Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626 |
Product Code | CHH |
CFR Regulation Number | 862.1175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-02-28 |
Decision Date | 2019-03-27 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10758750031764 | K190490 | 000 |