The following data is part of a premarket notification filed by American Sterilizer Co. with the FDA for Chemdi-vhp Chemical Indicator.
| Device ID | K922485 |
| 510k Number | K922485 |
| Device Name: | CHEMDI-VHP CHEMICAL INDICATOR |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | AMERICAN STERILIZER CO. 2424 WEST 23RD ST. P.O. BOX 620 Erie, PA 16514 |
| Contact | Michael J Zmuda |
| Correspondent | Michael J Zmuda AMERICAN STERILIZER CO. 2424 WEST 23RD ST. P.O. BOX 620 Erie, PA 16514 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-18 |
| Decision Date | 1993-09-29 |