K960777 is an FDA 510(k) clearance for the MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR. This device is classified as a Indicator, Biological Sterilization Process (Class II - Special Controls, product code FRC).
Submitted by Mdt Corp., Inc. (Rochester, US). The FDA issued a Cleared decision on May 23, 1996, 87 days after receiving the submission on February 26, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K960777 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 1996 |
| Decision Date | May 23, 1996 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRC — Indicator, Biological Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |