K020612 is an FDA 510(k) clearance for the SULTAN SPOROX TEST VIAL, MODEL 75195. This device is classified as a Indicator, Physical/chemical Sterilization Process (Class II - Special Controls, product code JOJ).
Submitted by Sultan Chemists, Inc. (Englewood, US). The FDA issued a Cleared decision on May 7, 2002, 71 days after receiving the submission on February 25, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K020612 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 2002 |
| Decision Date | May 07, 2002 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | JOJ — Indicator, Physical/chemical Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |