The following data is part of a premarket notification filed by Mesa Laboratories, Inc. with the FDA for Conductivity/tds Calibrator Solution.
| Device ID | K033330 |
| 510k Number | K033330 |
| Device Name: | CONDUCTIVITY/TDS CALIBRATOR SOLUTION |
| Classification | Solution-test Standard-conductivity, Dialysis |
| Applicant | MESA LABORATORIES, INC. 12100 WEST 6TH AVE. Lakewood, CO 80228 |
| Contact | Todd Romero |
| Correspondent | Todd Romero MESA LABORATORIES, INC. 12100 WEST 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 | 2003-10-16 |
| Decision Date | 2004-02-27 |
| Summary: | summary |