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FDA 510(k)

VERIFY Spore Test Strip for S40 Sterilant

K-Number: K180553 · 2018-05-29

ApplicantSTERIS Corporation
Decision Date2018-05-29
Product CodeOVY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VERIFY Spore Test Strip for S40 Sterilant is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2018-05-29 under 510(k) number K180553. The device is classified under product code OVY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERIFY Spore Test Strip for S40 Sterilant?

VERIFY Spore Test Strip for S40 Sterilant is a medical device that received FDA 510(k) clearance on 2018-05-29. The listed applicant is STERIS Corporation. The 510(k) number is K180553.

When did VERIFY Spore Test Strip for S40 Sterilant receive FDA 510(k) clearance?

VERIFY Spore Test Strip for S40 Sterilant received FDA 510(k) clearance on 2018-05-29, under 510(k) number K180553.

Who is the listed applicant for VERIFY Spore Test Strip for S40 Sterilant?

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 VERIFY Spore Test Strip for S40 Sterilant?

The FDA product code for VERIFY Spore Test Strip for S40 Sterilant is OVY.

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Related Devices (Code: OVY)

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.

K233682VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATESTERIS CorporationK231746VERIFY Spore Test Strip for S40 Sterilant ConcentrateSTERIS Corporation

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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