The following data is part of a premarket notification filed by Serim Research Corp. with the FDA for Serim Hisense Ultra 0.1, Part Number 5167.
| Device ID | K080712 |
| 510k Number | K080712 |
| Device Name: | SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 |
| Classification | Strip, Test, Reagent, Residuals For Dialysate, Disinfectant |
| Applicant | SERIM RESEARCH CORP. 23565 REEDY DR. Elkhart, IN 46514 |
| Contact | Patricia Rupchock |
| Correspondent | Patricia Rupchock SERIM RESEARCH CORP. 23565 REEDY DR. Elkhart, IN 46514 |
| Product Code | MSY |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-13 |
| Decision Date | 2008-05-06 |
| Summary: | summary |