K002401 is an FDA 510(k) clearance for the CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION). This device is classified as a Sterilant, Medical Devices (Class II - Special Controls, product code MED).
Submitted by Advanced Sterilization Products (Irvin, US). The FDA issued a Cleared decision on August 29, 2000, 22 days after receiving the submission on August 7, 2000.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6885.
| 510(k) Number | K002401 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 2000 |
| Decision Date | August 29, 2000 |
| Days to Decision | 22 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MED — Sterilant, Medical Devices |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6885 |