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FDA 510(k)

Anprolene SteriTest RRBI

K-Number: K213296 · 2022-04-12

ApplicantAndersen Sterilizers, Inc.
Decision Date2022-04-12
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Anprolene SteriTest RRBI is the device name listed in this FDA 510(k) record. The listed applicant is Andersen Sterilizers, Inc.. It received FDA 510(k) clearance on 2022-04-12 under 510(k) number K213296. 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 Anprolene SteriTest RRBI?

Anprolene SteriTest RRBI is a medical device that received FDA 510(k) clearance on 2022-04-12. The listed applicant is Andersen Sterilizers, Inc.. The 510(k) number is K213296.

When did Anprolene SteriTest RRBI receive FDA 510(k) clearance?

Anprolene SteriTest RRBI received FDA 510(k) clearance on 2022-04-12, under 510(k) number K213296.

Who is the listed applicant for Anprolene SteriTest RRBI?

The FDA 510(k) record lists Andersen Sterilizers, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anprolene SteriTest RRBI?

The FDA product code for Anprolene SteriTest RRBI is FRC.

Other records listing Andersen Sterilizers, Inc. as applicant

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Related Devices (Code: 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.

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