The following data is part of a premarket notification filed by Sterilucent, Inc. with the FDA for Sterilucent Self-contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device.
| Device ID | K192001 |
| 510k Number | K192001 |
| Device Name: | Sterilucent Self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | Sterilucent, Inc. 1400 Marshall St. NE Minneapolis, MN 55413 |
| Contact | Peter Kalkbrenner |
| Correspondent | Peter Kalkbrenner Sterilucent, Inc. 1400 Marshall St. 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 | 2019-07-26 |
| Decision Date | 2019-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850012210078 | K192001 | 000 |
| 00850012210054 | K192001 | 000 |