K113302 is an FDA 510(k) clearance for the NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS. This device is classified as a Indicator, Biological Sterilization Process (Class II - Special Controls, product code FRC).
Submitted by North American Science Assoc., Inc. (Northwood, US). The FDA issued a Cleared decision on January 20, 2012, 73 days after receiving the submission on November 8, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K113302 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2011 |
| Decision Date | January 20, 2012 |
| Days to Decision | 73 days |
| Submission Type | Abbreviated |
| 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 |