The following data is part of a premarket notification filed by Castle Co. with the FDA for Unispore-biological Indicators.
| Device ID | K792649 |
| 510k Number | K792649 |
| Device Name: | UNISPORE-BIOLOGICAL INDICATORS |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | CASTLE CO. 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 | 1979-12-21 |
| Decision Date | 1980-01-29 |