The following data is part of a premarket notification filed by Mesa Laboratories, Inc. with the FDA for Tds Standard Solution.
| Device ID | K191496 |
| 510k Number | K191496 |
| Device Name: | TDS Standard Solution |
| Classification | Solution-test Standard-conductivity, Dialysis |
| Applicant | Mesa Laboratories, Inc. 12100 West 6th Avenue Lakewood, CO 80228 |
| Contact | Jamie Louie |
| Correspondent | Jamie Louie Mesa Laboratories, Inc. 12100 West 6th Avenue 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 | 2019-06-05 |
| Decision Date | 2019-08-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M985020583 | K191496 | 000 |
| M985020582 | K191496 | 000 |
| M985020081 | K191496 | 000 |
| M985020080 | K191496 | 000 |
| M985020079 | K191496 | 000 |