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FDA 510(k)

Anprolene SteriTest

K-Number: K170427 · 2017-10-31

ApplicantAndersen Sterilizers, Inc.
Decision Date2017-10-31
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Anprolene SteriTest 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 2017-10-31 under 510(k) number K170427. 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?

Anprolene SteriTest is a medical device that received FDA 510(k) clearance on 2017-10-31. The listed applicant is Andersen Sterilizers, Inc.. The 510(k) number is K170427.

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

Anprolene SteriTest received FDA 510(k) clearance on 2017-10-31, under 510(k) number K170427.

Who is the listed applicant for Anprolene SteriTest?

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?

The FDA product code for Anprolene SteriTest 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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