The following data is part of a premarket notification filed by Roche Professional Diagnostics with the FDA for Anti-hav.
| Device ID | K100903 |
| 510k Number | K100903 |
| Device Name: | ANTI-HAV |
| Classification | Hepatitis A Test (antibody And Igm Antibody) |
| Applicant | ROCHE PROFESSIONAL DIAGNOSTICS 9115 HAGUE ROAD P.O. BOX 50410 Indianapolis, IN |
| Contact | Kelly French |
| Correspondent | Kelly French ROCHE PROFESSIONAL DIAGNOSTICS 9115 HAGUE ROAD P.O. BOX 50410 Indianapolis, IN |
| Product Code | LOL |
| CFR Regulation Number | 866.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-01 |
| Decision Date | 2010-10-05 |