The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vidas H. Pylori Igg (hpy) Assay, Model 30 192.
| Device ID | K001460 |
| 510k Number | K001460 |
| Device Name: | VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192 |
| Classification | Helicobacter Pylori |
| Applicant | BIOMERIEUX, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Contact | Janet Connolly |
| Correspondent | Janet Connolly BIOMERIEUX, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-10 |
| Decision Date | 2000-10-04 |