Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device— 510(k) K192001
Substantially EquivalentSterilucent, Inc.
FDA 510(k) clearance K192001 for Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device, Substantially Equivalent on 2019-10-22. Applicant: Sterilucent, Inc.. Device class: 2.
Clearance details
- Applicant
- Sterilucent, Inc.
- Product code
- Code FRC
- Device class
- Class 2
- Regulation
- 21 CFR 880.2800
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
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