Self-Contained Biological Indicator
K-Number: K200970 · 2020-12-28
ApplicantTrue Indicating, LLC
Decision Date2020-12-28
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Self-Contained Biological Indicator is a medical device manufactured by True Indicating, LLC. It received FDA 510(k) clearance on 2020-12-28 under approval number K200970. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Self-Contained Biological Indicator?
Self-Contained Biological Indicator is a medical device that received FDA 510(k) clearance on 2020-12-28. It is manufactured by True Indicating, LLC. The 510(k) number is K200970.
When was Self-Contained Biological Indicator approved by the FDA?
Self-Contained Biological Indicator received FDA 510(k) clearance on 2020-12-28, under approval number K200970.
What company makes Self-Contained Biological Indicator?
Self-Contained Biological Indicator is manufactured by True Indicating, LLC.
What is the FDA product code for Self-Contained Biological Indicator?
The FDA product code for Self-Contained Biological Indicator is FRC.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.