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FDA 510(k)

Micro-MEC 1.8% Glutaraldehyde Monitor Strip

K-Number: K172472 · 2017-11-17

ApplicantSTERIS Corporation
Decision Date2017-11-17
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Micro-MEC 1.8% Glutaraldehyde Monitor Strip is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2017-11-17 under 510(k) number K172472. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Micro-MEC 1.8% Glutaraldehyde Monitor Strip?

Micro-MEC 1.8% Glutaraldehyde Monitor Strip is a medical device that received FDA 510(k) clearance on 2017-11-17. The listed applicant is STERIS Corporation. The 510(k) number is K172472.

When did Micro-MEC 1.8% Glutaraldehyde Monitor Strip receive FDA 510(k) clearance?

Micro-MEC 1.8% Glutaraldehyde Monitor Strip received FDA 510(k) clearance on 2017-11-17, under 510(k) number K172472.

Who is the listed applicant for Micro-MEC 1.8% Glutaraldehyde Monitor Strip?

The FDA 510(k) record lists STERIS Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Micro-MEC 1.8% Glutaraldehyde Monitor Strip?

The FDA product code for Micro-MEC 1.8% Glutaraldehyde Monitor Strip is JOJ.

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Related Devices (Code: JOJ)

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.

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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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