K083665 is an FDA 510(k) clearance for the VERIFY SCBI 275F 3-10. This device is classified as a Indicator, Biological Sterilization Process (Class II - Special Controls, product code FRC).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on September 1, 2009, 265 days after receiving the submission on December 10, 2008.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K083665 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 2008 |
| Decision Date | September 01, 2009 |
| Days to Decision | 265 days |
| Submission Type | Abbreviated |
| 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 |