gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)
FDA 510(k) clearance K163144 · decided 2017-04-07
Clearance details
- K-number
- K163144
- Device name
- gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)
- Applicant
- Gke-GmbH
- Decision
- Substantially Equivalent
- Date received
- 2016-11-09
- Decision date
- 2017-04-07
- Days to decision
- 149 days
- Clearance type
- Traditional
- Product code
- FRC
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Waldems, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.