The following data is part of a premarket notification filed by Serim Research Corp. with the FDA for Serim Dialysate Monitor Test Strip.
| Device ID | K043031 |
| 510k Number | K043031 |
| Device Name: | SERIM DIALYSATE MONITOR TEST STRIP |
| Classification | Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator |
| Applicant | SERIM RESEARCH CORP. 23565 REEDY DR. Elkhart, IN 46514 |
| Contact | Patricia A Rupchock |
| Correspondent | Patricia A Rupchock SERIM RESEARCH CORP. 23565 REEDY DR. Elkhart, IN 46514 |
| Product Code | NTZ |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-03 |
| Decision Date | 2005-06-13 |
| Summary: | summary |