The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Sterrad Chemical Indicator Tape.
| Device ID | K945190 |
| 510k Number | K945190 |
| Device Name: | STERRAD CHEMICAL INDICATOR TAPE |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Contact | Truc Le |
| Correspondent | Truc Le ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-24 |
| Decision Date | 1994-12-29 |