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FDA 510(k)

BROWNE OPA TEST STRIP

K-Number: K081427 · 2008-06-11

ApplicantSTERIS Corporation
Decision Date2008-06-11
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BROWNE OPA TEST 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 2008-06-11 under 510(k) number K081427. 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 BROWNE OPA TEST STRIP?

BROWNE OPA TEST STRIP is a medical device that received FDA 510(k) clearance on 2008-06-11. The listed applicant is STERIS Corporation. The 510(k) number is K081427.

When did BROWNE OPA TEST STRIP receive FDA 510(k) clearance?

BROWNE OPA TEST STRIP received FDA 510(k) clearance on 2008-06-11, under 510(k) number K081427.

Who is the listed applicant for BROWNE OPA TEST 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 BROWNE OPA TEST STRIP?

The FDA product code for BROWNE OPA TEST 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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