The following data is part of a premarket notification filed by Mesa Laboratories, Inc. with the FDA for Smart Read Eztest Steam.
| Device ID | K112018 |
| 510k Number | K112018 |
| Device Name: | SMART READ EZTEST STEAM |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | MESA LABORATORIES, INC. 10 EVERGREEN DRIVE Bozeman, MT 59715 |
| Contact | Wendy Royalty |
| Correspondent | Wendy Royalty MESA LABORATORIES, INC. 10 EVERGREEN DRIVE Bozeman, MT 59715 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-14 |
| Decision Date | 2012-01-30 |
| Summary: | summary |