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  |