The following data is part of a premarket notification filed by Serim Research Corp. with the FDA for Serim Pyloritek Test Kit.
| Device ID | K953632 |
| 510k Number | K953632 |
| Device Name: | SERIM PYLORITEK TEST KIT |
| Classification | Helicobacter Pylori |
| Applicant | SERIM RESEARCH CORP. 1000 RANDOLPH ST., BLDG. 17 P.O. BOX 4002 Elkhart, IN 46514 -0002 |
| Contact | Robert J Carrico |
| Correspondent | Robert J Carrico SERIM RESEARCH CORP. 1000 RANDOLPH ST., BLDG. 17 P.O. BOX 4002 Elkhart, IN 46514 -0002 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-20 |
| Decision Date | 1995-12-18 |