K133549 is an FDA 510(k) clearance for the STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR. This device is classified as a Indicator, Biological Sterilization Process (Class II - Special Controls, product code FRC).
Submitted by Steritec Products Mfg Co, Inc. (Engelwood, US). The FDA issued a Cleared decision on August 27, 2014, 281 days after receiving the submission on November 19, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K133549 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 2013 |
| Decision Date | August 27, 2014 |
| Days to Decision | 281 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FRC - Indicator, Biological Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |