The following data is part of a premarket notification filed by Gke-gmbh with the FDA for Gke Steri-record Steam Mini-bio-plus Self-contained Biological Indicator (scbi).
| Device ID | K163144 |
| 510k Number | K163144 |
| Device Name: | Gke Steri-Record Steam Mini-Bio-Plus Self-contained Biological Indicator (SCBI) |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | GKE-GMBH AUF DER LIND 10 Waldems, DE 65529 |
| Contact | Ulrich Kaiser |
| Correspondent | Ulrich Kaiser GKE-GMBH AUF DER LIND 10 Waldems, DE 65529 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-09 |
| Decision Date | 2017-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00060705811547 | K163144 | 000 |