K955426 is an FDA 510(k) clearance for the STERITEC CROSS-CHECKS. This device is classified as a Indicator, Physical/chemical Sterilization Process (Class II - Special Controls, product code JOJ).
Submitted by Steritec Products Mfg Co, Inc. (Castle Rock, US). The FDA issued a Cleared decision on March 12, 1996, 105 days after receiving the submission on November 28, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K955426 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 1995 |
| Decision Date | March 12, 1996 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | JOJ - Indicator, Physical/chemical Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |