Submission Details
| 510(k) Number | K080712 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 13, 2008 |
| Decision Date | May 06, 2008 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
Cleared
Traditional
K080712 - SERIM HISENSE ULTRA 0.1, PART NUMBER 5167
(FDA 510(k) Clearance)
May 2008
Decision
54d
Days
Class 2
Risk
K080712 is an FDA 510(k) clearance for the SERIM HISENSE ULTRA 0.1, PART NUMBER 5167, a Strip, Test, Reagent, Residuals For Dialysate, Disinfectant (Class II — Special Controls, product code MSY), submitted by Serim Research Corp. (Elkhart, US). The FDA issued a Cleared decision on May 6, 2008, 54 days after receiving the submission on March 13, 2008. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5665.
Device Classification
| Product Code | MSY — Strip, Test, Reagent, Residuals For Dialysate, Disinfectant |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5665 |
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