The following data is part of a premarket notification filed by Biohit Plc with the FDA for Helicobacter Pylori Igg Elisa.
| Device ID | K041238 |
| 510k Number | K041238 |
| Device Name: | HELICOBACTER PYLORI IGG ELISA |
| Classification | Helicobacter Pylori |
| Applicant | BIOHIT PLC 3535 ROUTE 66 BUILDING 4 Neptune, NJ 07753 |
| Contact | Robert P Gearty |
| Correspondent | Robert P Gearty BIOHIT PLC 3535 ROUTE 66 BUILDING 4 Neptune, NJ 07753 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-11 |
| Decision Date | 2004-12-13 |
| Summary: | summary |