The following data is part of a premarket notification filed by Mesa Laboratories, Inc. with the FDA for Comined Standard Solution.
| Device ID | K130100 |
| 510k Number | K130100 |
| Device Name: | COMINED STANDARD SOLUTION |
| Classification | Solution-test Standard-conductivity, Dialysis |
| Applicant | MESA LABORATORIES, INC. 12100 W 6th Ave Lakewood, CO 80228 |
| Contact | Jamie Louie |
| Correspondent | Jamie Louie MESA LABORATORIES, INC. 12100 W 6th Ave Lakewood, CO 80228 |
| Product Code | FKH |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-15 |
| Decision Date | 2013-04-18 |
| Summary: | summary |