Lakewood, Colorado, March 28th 2013
Mesa Labs, a Colorado-based process monitoring and validation solutions provider, has received 510(k) notification from the Food and Drug Administration for their new Smart-Well 1710 Biological Indicator Incubator.
Mesa Labs is pleased to announce that it has received 510(k) notification for its new 1710 Smart-Well® Incubator–part of the Smart-Read® Biological Indicator Monitoring System. The 1710 Smart-Well® is an advancement of Mesa’s earlier edition Smart-Well incubator (Model 1701) which is a true biological system that provides fast biological results, automatic documentation and easy, one-step evaluation.
The 1710 model offers these enhanced features:
- Dual Integrated Digital Thermometers
- Improved Processor and Storage
- Larger, Color LCD Interface
- Password Protection
- Temperature Progress Meter
The Smart-Well® Biological Indicator Monitoring system uses a real biological indicator (BI) — with no added enzyme or chemical integrator — which is incubated, evaluated, and documented in one simple, automated operation. Relying only upon bacterial spore growth, the Smart-Read® system can detect sterilization failure in as few as three to five hours, and negative results can be confirmed with an additional five hours of incubation.
The Smart-Read® system includes the Smart-Read® EZTest self-contained biological indicator which is specially designed for rapid evaluation in Mesa’s advanced Smart-Well® incubator.
Mesa Laboratories, Inc. (MLAB on the NASDAQ) offers biological indicators through its Bozeman, MT and Omaha,NE manufacturing facilities. Mesa also manufactures dialysis meters, gas flow meters, data loggers and torque testers.
To learn more, visit mesalabs.com