K844479 is an FDA 510(k) clearance for the CHEMSPOR. This device is classified as a Indicator, Biological Sterilization Process (Class II - Special Controls, product code FRC).
Submitted by American Sterilizer Co. (Erie, US). The FDA issued a Cleared decision on November 25, 1985, 371 days after receiving the submission on November 19, 1984.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K844479 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | November 19, 1984 |
| Decision Date | November 25, 1985 |
| Days to Decision | 371 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FRC — Indicator, Biological Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |