Self-Contained Biological Indicator— 510(k) K200970
Substantially EquivalentTrue Indicating, LLC
FDA 510(k) clearance K200970 for Self-Contained Biological Indicator, Substantially Equivalent on 2020-12-28. Applicant: True Indicating, LLC. Device class: 2.
Clearance details
- Applicant
- True Indicating, LLC
- 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
- Toledo, OH, US
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