The following data is part of a premarket notification filed by Panion & Bf Biotech Inc. with the FDA for Vstrip H. Pylori Antigen Rapid Test.
| Device ID | K183573 |
| 510k Number | K183573 |
| Device Name: | Vstrip H. Pylori Antigen Rapid Test |
| Classification | Helicobacter Pylori |
| Applicant | Panion & BF Biotech Inc. 6F.-3, No.306, Sec. 1, Datong Rd., Xizhi Dist. New Taipei City, TW 22146 |
| Contact | Ching Sui A. Yi |
| Correspondent | Kazem Kazempour Amarex Clinical Research, LLC 20201 Century Blvd, Fourth Floor Germantown, MD 20874 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-21 |
| Decision Date | 2019-03-14 |