The following data is part of a premarket notification filed by Steritec Products Mfg. Co., Inc. with the FDA for Smart Read Biological Test Pack.
| Device ID | K103000 |
| 510k Number | K103000 |
| Device Name: | SMART READ BIOLOGICAL TEST PACK |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | STERITEC PRODUCTS MFG. CO., INC. 74 INVERNESS DRIVE EAST Englewood, CO 80112 |
| Contact | Suzanne Dennis |
| Correspondent | Suzanne Dennis STERITEC PRODUCTS MFG. CO., INC. 74 INVERNESS DRIVE EAST Englewood, CO 80112 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-08 |
| Decision Date | 2011-02-11 |