The following data is part of a premarket notification filed by American Sterilizer Co. with the FDA for Chemdi Steam & Gas Sterilization Indica.
| Device ID | K823074 |
| 510k Number | K823074 |
| Device Name: | CHEMDI STEAM & GAS STERILIZATION INDICA |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | AMERICAN STERILIZER CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-19 |
| Decision Date | 1982-11-08 |