The following data is part of a premarket notification filed by Serim Research Corp. with the FDA for Pyloritek Vp Test Kit 5140vp.
| Device ID | K014038 |
| 510k Number | K014038 |
| Device Name: | PYLORITEK VP TEST KIT 5140VP |
| Classification | Helicobacter Pylori |
| Applicant | SERIM RESEARCH CORP. 23565 REEDY DR. Elkhart, IN 46514 |
| Contact | Patricia Rupuchock |
| Correspondent | Patricia Rupuchock SERIM RESEARCH CORP. 23565 REEDY DR. Elkhart, IN 46514 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-07 |
| Decision Date | 2002-02-08 |
| Summary: | summary |