K141238 is an FDA 510(k) clearance for the STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR. 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 November 3, 2014, 174 days after receiving the submission on May 13, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K141238 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2014 |
| Decision Date | November 03, 2014 |
| Days to Decision | 174 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 |