The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Chemistry Products Dtibc Reagent.
| Device ID | K052867 |
| 510k Number | K052867 |
| Device Name: | VITROS CHEMISTRY PRODUCTS DTIBC REAGENT |
| Classification | Ferrozine (colorimetric) Iron Binding Capacity |
| Applicant | Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Contact | Darlene J Phillips |
| Correspondent | Darlene J Phillips Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Product Code | JMO |
| Subsequent Product Code | JIS |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-11 |
| Decision Date | 2005-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750001873 | K052867 | 000 |
| 10758750002702 | K052867 | 000 |
| 10758750002696 | K052867 | 000 |