The following data is part of a premarket notification filed by Andersen Sterilizers, Inc. with the FDA for Andersen Eogas 4 Steritest.
| Device ID | K151585 |
| 510k Number | K151585 |
| Device Name: | Andersen EOGas 4 SteriTest |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | Andersen Sterilizers, Inc. 3154 Caroline Drive Haw River, NC 27258 |
| Contact | William K Andersen |
| Correspondent | William K Andersen Andersen Sterilizers, Inc. 3154 Caroline Drive Haw River, NC 27258 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-11 |
| Decision Date | 2015-11-18 |
| Summary: | summary |