The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Anti-hav Igm.
| Device ID | K093955 |
| 510k Number | K093955 |
| Device Name: | ANTI-HAV IGM |
| Classification | Hepatitis A Test (antibody And Igm Antibody) |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Contact | Kelly French |
| Correspondent | Kelly French Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Product Code | LOL |
| CFR Regulation Number | 866.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-23 |
| Decision Date | 2010-06-22 |
| Summary: | summary |