The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Afp.
| Device ID | K220176 |
| 510k Number | K220176 |
| Device Name: | Elecsys AFP |
| Classification | Kit, Test,alpha-fetoprotein For Testicular Cancer |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Jamie Ferguson |
| Correspondent | Jamie Ferguson Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | LOJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-21 |
| Decision Date | 2022-09-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336206164 | K220176 | 000 |
| 07613336206157 | K220176 | 000 |
| 07613336172025 | K220176 | 000 |
| 07613336217146 | K220176 | 000 |