K974064 is an FDA 510(k) clearance for the MICRO X RESIDUAL TEST STRIPS. This device is classified as a Strip, Test, Reagent, Residuals For Dialysate, Disinfectant (Class II - Special Controls, product code MSY).
Submitted by Reprocessing Products Corp (Maple Grove, US). The FDA issued a Cleared decision on December 7, 1998, 406 days after receiving the submission on October 27, 1997.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5665.
| 510(k) Number | K974064 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 1997 |
| Decision Date | December 07, 1998 |
| Days to Decision | 406 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MSY — Strip, Test, Reagent, Residuals For Dialysate, Disinfectant |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5665 |