The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Sterrad (r) 100nx Duo Cycle Test Pack.
| Device ID | K111391 |
| 510k Number | K111391 |
| Device Name: | STERRAD (R) 100NX DUO CYCLE TEST PACK |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Contact | Nancy Chu |
| Correspondent | Nancy Chu ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-18 |
| Decision Date | 2012-09-26 |
| Summary: | summary |