K080750 is an FDA 510(k) clearance for the BROWNE RAPICIDE GLUTARALDEHYDE INDICATOR. This device is classified as a Indicator, Physical/chemical Sterilization Process (Class II - Special Controls, product code JOJ).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on May 12, 2008, 56 days after receiving the submission on March 17, 2008.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K080750 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 2008 |
| Decision Date | May 12, 2008 |
| Days to Decision | 56 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 |