The following data is part of a premarket notification filed by Sybron Corp. with the FDA for Castle Tec-test Biological Indicator.
| Device ID | K812272 |
| 510k Number | K812272 |
| Device Name: | CASTLE TEC-TEST BIOLOGICAL INDICATOR |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | SYBRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-13 |
| Decision Date | 1981-09-08 |