K132291 is an FDA 510(k) clearance for the NAMSA CHEMICAL PROCESS. This device is classified as a Indicator, Physical/chemical Sterilization Process (Class II - Special Controls, product code JOJ).
Submitted by North American Science Assoc., Inc. (Toledo, US). The FDA issued a Cleared decision on May 20, 2014, 301 days after receiving the submission on July 23, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K132291 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2013 |
| Decision Date | May 20, 2014 |
| Days to Decision | 301 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | JOJ — Indicator, Physical/chemical Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |