The following data is part of a premarket notification filed by Otsuka Pharmaceutical Co., Ltd. with the FDA for Rapirun H. Pylori Antibody Detection Kit.
| Device ID | K052716 |
| 510k Number | K052716 |
| Device Name: | RAPIRUN H. PYLORI ANTIBODY DETECTION KIT |
| Classification | Helicobacter Pylori |
| Applicant | OTSUKA PHARMACEUTICAL CO., LTD. 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Cynthia A Sinclair |
| Correspondent | Cynthia A Sinclair OTSUKA PHARMACEUTICAL CO., LTD. 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-29 |
| Decision Date | 2006-11-16 |
| Summary: | summary |