K043031 is an FDA 510(k) clearance for the SERIM DIALYSATE MONITOR TEST STRIP. This device is classified as a Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator (Class II - Special Controls, product code NTZ).
Submitted by Serim Research Corp. (Elkhart, US). The FDA issued a Cleared decision on June 13, 2005, 222 days after receiving the submission on November 3, 2004.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820. Device Provides Semiquantitative Indications Of Ph, Bicarbonate Ions, And Glucose In The Final Bicarbonate Dialysate..
| 510(k) Number | K043031 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 2004 |
| Decision Date | June 13, 2005 |
| Days to Decision | 222 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NTZ — Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |
| Definition | Device Provides Semiquantitative Indications Of Ph, Bicarbonate Ions, And Glucose In The Final Bicarbonate Dialysate. |