K051643 is an FDA 510(k) clearance for the STERRAD STERILIZER CYCLESURE 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 August 19, 2005, 60 days after receiving the submission on June 20, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K051643 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2005 |
| Decision Date | August 19, 2005 |
| Days to Decision | 60 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 |