The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Sterraad 100nx Express Cycle Test Pack.
| Device ID | K092755 |
| 510k Number | K092755 |
| Device Name: | STERRAAD 100NX EXPRESS 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 | 2009-09-09 |
| Decision Date | 2011-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705037016396 | K092755 | 000 |