The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Anti-hav Ii.
| Device ID | K190428 |
| 510k Number | K190428 |
| Device Name: | Elecsys Anti-HAV II |
| Classification | Hepatitis A Test (antibody And Igm Antibody) |
| Applicant | Roche Diagnostics 9115 Hague Road, PO Box 50416 Indianapolis, IN 46250 |
| Contact | Jamie Ferguson |
| Correspondent | Jamie Ferguson Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | LOL |
| CFR Regulation Number | 866.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-22 |
| Decision Date | 2019-08-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336129746 | K190428 | 000 |
| 07613336129722 | K190428 | 000 |
| 07613336129715 | K190428 | 000 |