K071537 is an FDA 510(k) clearance for the STERRAD 100NX TEST PACK. This device is classified as a Indicator, Biological Sterilization Process (Class II - Special Controls, product code FRC).
Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on December 18, 2007, 196 days after receiving the submission on June 5, 2007.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K071537 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 2007 |
| Decision Date | December 18, 2007 |
| Days to Decision | 196 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 |