The following data is part of a premarket notification filed by True Indicating Llc with the FDA for Chemical Indicator For Steam.
| Device ID | K220778 |
| 510k Number | K220778 |
| Device Name: | Chemical Indicator For Steam |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | True Indicating LLC 946 Kane St Toledo, OH 43612 |
| Contact | Thomas Riha |
| Correspondent | Thomas Riha True Indicating LLC 946 Kane St Toledo, OH 43612 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-17 |
| Decision Date | 2022-12-02 |