The following data is part of a premarket notification filed by Gold Standard Diagnostics with the FDA for Helicobacter Pylori Elisa Igg Test Kit.
| Device ID | K110745 |
| 510k Number | K110745 |
| Device Name: | HELICOBACTER PYLORI ELISA IGG TEST KIT |
| Classification | Helicobacter Pylori |
| Applicant | GOLD STANDARD DIAGNOSTICS 2851 SPAFFORD Davis, CA 95618 |
| Contact | Napoleon Monce |
| Correspondent | Napoleon Monce GOLD STANDARD DIAGNOSTICS 2851 SPAFFORD Davis, CA 95618 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-17 |
| Decision Date | 2012-03-02 |
| Summary: | summary |