The following data is part of a premarket notification filed by Amsco Co. with the FDA for Biological/chemical Indicator.
| Device ID | K772135 |
| 510k Number | K772135 |
| Device Name: | BIOLOGICAL/CHEMICAL INDICATOR |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | AMSCO CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-11-14 |
| Decision Date | 1977-12-08 |