K823074 is an FDA 510(k) clearance for the CHEMDI STEAM & GAS STERILIZATION INDICA. This device is classified as a Indicator, Physical/chemical Sterilization Process (Class II - Special Controls, product code JOJ).
Submitted by American Sterilizer Co. (Walker, US). The FDA issued a Cleared decision on November 8, 1982, 20 days after receiving the submission on October 19, 1982.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K823074 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 1982 |
| Decision Date | November 08, 1982 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | JOJ — Indicator, Physical/chemical Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |