The following data is part of a premarket notification filed by Steritec Products Mfg., Co., Inc. with the FDA for Steritec Smart-read Biological Test Pack With Instant Readout Integrator.
| Device ID | K133322 |
| 510k Number | K133322 |
| Device Name: | STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | STERITEC PRODUCTS MFG., CO., INC. 74 INVERNESS DRIVE EAST Englewood, CO 80112 |
| Contact | Jonathan Rutigliano |
| Correspondent | Jonathan Rutigliano STERITEC PRODUCTS MFG., CO., INC. 74 INVERNESS DRIVE EAST Englewood, CO 80112 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-29 |
| Decision Date | 2014-08-25 |