The following data is part of a premarket notification filed by Serim Research Corp. with the FDA for Serim Pyloritek Reagent Strips.
| Device ID | K936034 |
| 510k Number | K936034 |
| Device Name: | SERIM PYLORITEK REAGENT STRIPS |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | SERIM RESEARCH CORP. P.O. BOX 4002 Elkhart, IN 46514 -0002 |
| Contact | J. Michael Mckenna |
| Correspondent | J. Michael Mckenna SERIM RESEARCH CORP. P.O. BOX 4002 Elkhart, IN 46514 -0002 |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-15 |
| Decision Date | 1994-04-21 |