The following data is part of a premarket notification filed by Sterilucent, Inc with the FDA for Sterilucent Process Challenge Device.
| Device ID | K141312 |
| 510k Number | K141312 |
| Device Name: | STERILUCENT PROCESS CHALLENGE DEVICE |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | STERILUCENT, INC 1400 MARSHALL STREET NE Minneapolis, MN 55413 |
| Contact | Peter Kalkbrenner |
| Correspondent | Peter Kalkbrenner STERILUCENT, INC 1400 MARSHALL STREET NE Minneapolis, MN 55413 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-20 |
| Decision Date | 2014-10-31 |
| Summary: | summary |