K922212 is an FDA 510(k) clearance for the MDT CASTLE BIOSIGN TEST PACK. 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 August 10, 1992, 90 days after receiving the submission on May 12, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K922212 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 1992 |
| Decision Date | August 10, 1992 |
| Days to Decision | 90 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 |