Self-Contained Biological Indicator
K-Number: K200970 · 2020-12-28
Device Summary
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. The listed applicant is True Indicating, LLC. The 510(k) number is K200970.
When did Self-Contained Biological Indicator receive FDA 510(k) clearance?
Self-Contained Biological Indicator received FDA 510(k) clearance on 2020-12-28, under 510(k) number K200970.
Who is the listed applicant for Self-Contained Biological Indicator?
The FDA 510(k) record lists True Indicating, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Self-Contained Biological Indicator?
The FDA product code for Self-Contained Biological Indicator is FRC.
Other records listing True Indicating, LLC as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: FRC)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.