K132372 is an FDA 510(k) clearance for the STERITEC GREEN CARD PACK BOWIE-DICK TEST. 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. (Engelwood, US). The FDA issued a Cleared decision on November 26, 2013, 119 days after receiving the submission on July 30, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K132372 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 2013 |
| Decision Date | November 26, 2013 |
| Days to Decision | 119 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 |