The following data is part of a premarket notification filed by Ortho Clinical Diagnostics with the FDA for Vitros Chemistry Products Hscrp Reagent.
| Device ID | K160712 |
| 510k Number | K160712 |
| Device Name: | VITROS Chemistry Products HsCRP Reagent |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | Ortho Clinical Diagnostics 100 Indigo Creek Drive Rochester, NY 14626 |
| Contact | Marlene Hanna |
| Correspondent | Marlene Hanna Ortho Clinical Diagnostics 100 Indigo Creek Drive Rochester, NY 14626 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-15 |
| Decision Date | 2017-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750006915 | K160712 | 000 |
| 10758750001965 | K160712 | 000 |
| 10758750001637 | K160712 | 000 |