K951113 is an FDA 510(k) clearance for the CROSS-CHECKS. This device is classified as a Indicator, Sterilization (Class II - Special Controls, product code LRT).
Submitted by Steritec Products Mfg Co, Inc. (Castle Rock, US). The FDA issued a Cleared decision on August 19, 1996, 528 days after receiving the submission on March 10, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K951113 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 1995 |
| Decision Date | August 19, 1996 |
| Days to Decision | 528 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LRT - Indicator, Sterilization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |