The following data is part of a premarket notification filed by American Sterilizer Co. with the FDA for Chemdi.
| Device ID | K801428 |
| 510k Number | K801428 |
| Device Name: | CHEMDI |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | AMERICAN STERILIZER 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 | 1980-06-17 |
| Decision Date | 1980-08-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CHEMDI 73073142 1046200 Live/Registered |
AMERICAN STERILIZER COMPANY 1975-12-31 |