The following data is part of a premarket notification filed by Ortho Clinical Diagnostics with the FDA for Vitros Afp.
| Device ID | K213626 |
| 510k Number | K213626 |
| Device Name: | VITROS AFP |
| Classification | Kit, Test,alpha-fetoprotein For Testicular Cancer |
| Applicant | Ortho Clinical Diagnostics Felindre Meadows Pencoed, GB CF35 5PZ |
| Contact | Declan Hynes |
| Correspondent | Declan Hynes Ortho Clinical Diagnostics Felindre Meadows Pencoed, GB CF35 5PZ |
| Product Code | LOJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-17 |
| Decision Date | 2022-06-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750034819 | K213626 | 000 |