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FDA 510(k)

OXOID PYLORI TEST KIT, MODEL DR0130M

K-Number: K012588 · 2001-12-10

ApplicantOxoid , Ltd.
Decision Date2001-12-10
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

OXOID PYLORI TEST KIT, MODEL DR0130M is the device name listed in this FDA 510(k) record. The listed applicant is Oxoid , Ltd.. It received FDA 510(k) clearance on 2001-12-10 under 510(k) number K012588. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXOID PYLORI TEST KIT, MODEL DR0130M?

OXOID PYLORI TEST KIT, MODEL DR0130M is a medical device that received FDA 510(k) clearance on 2001-12-10. The listed applicant is Oxoid , Ltd.. The 510(k) number is K012588.

When did OXOID PYLORI TEST KIT, MODEL DR0130M receive FDA 510(k) clearance?

OXOID PYLORI TEST KIT, MODEL DR0130M received FDA 510(k) clearance on 2001-12-10, under 510(k) number K012588.

Who is the listed applicant for OXOID PYLORI TEST KIT, MODEL DR0130M?

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

What is the FDA product code for OXOID PYLORI TEST KIT, MODEL DR0130M?

The FDA product code for OXOID PYLORI TEST KIT, MODEL DR0130M is LYR.

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Other records listing Oxoid , Ltd. as applicant

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Related Devices (Code: LYR)

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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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