K113221 is an FDA 510(k) clearance for the NAMSA BIOLOGICAL INDICATOR SPORE STRIPS. 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 April 27, 2012, 178 days after receiving the submission on November 1, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K113221 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2011 |
| Decision Date | April 27, 2012 |
| Days to Decision | 178 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 |