K141312 is an FDA 510(k) clearance for the STERILUCENT PROCESS CHALLENGE DEVICE. This device is classified as a Indicator, Biological Sterilization Process (Class II - Special Controls, product code FRC).
Submitted by Sterilucent, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 31, 2014, 164 days after receiving the submission on May 20, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K141312 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2014 |
| Decision Date | October 31, 2014 |
| Days to Decision | 164 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 |