K112018 is an FDA 510(k) clearance for the SMART READ EZTEST STEAM. This device is classified as a Indicator, Biological Sterilization Process (Class II - Special Controls, product code FRC).
Submitted by Mesa Laboratories, Inc. (Bozeman, US). The FDA issued a Cleared decision on January 30, 2012, 200 days after receiving the submission on July 14, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K112018 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 2011 |
| Decision Date | January 30, 2012 |
| Days to Decision | 200 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRC - Indicator, Biological Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |