The following data is part of a premarket notification filed by Abtox, Inc. with the FDA for Abtox Serilization Process Biological Indicator.
| Device ID | K923739 |
| 510k Number | K923739 |
| Device Name: | ABTOX SERILIZATION PROCESS BIOLOGICAL INDICATOR |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | ABTOX, INC. 104 TERRACE DR. Mundelein, IL 60060 |
| Contact | Bob Riley |
| Correspondent | Bob Riley ABTOX, INC. 104 TERRACE DR. Mundelein, IL 60060 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-27 |
| Decision Date | 1994-12-22 |