K150645 is an FDA 510(k) clearance for the AN1087 Dosimeter. This device is classified as a Indicator, Physical/chemical Sterilization Process (Class II - Special Controls, product code JOJ).
Submitted by Andersen Sterilizers, Inc. (Haw River, US). The FDA issued a Cleared decision on November 19, 2015, 252 days after receiving the submission on March 12, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K150645 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2015 |
| Decision Date | November 19, 2015 |
| Days to Decision | 252 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 |