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FDA 510(k)

BREATHTEK - UBIT UBT FOR H. PYLORI

K-Number: K014225 · 2002-01-17

ApplicantMeretek Diagnostics, Inc.
Decision Date2002-01-17
Product CodeMSQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BREATHTEK - UBIT UBT FOR H. PYLORI is the device name listed in this FDA 510(k) record. The listed applicant is Meretek Diagnostics, Inc.. It received FDA 510(k) clearance on 2002-01-17 under 510(k) number K014225. The device is classified under product code MSQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREATHTEK - UBIT UBT FOR H. PYLORI?

BREATHTEK - UBIT UBT FOR H. PYLORI is a medical device that received FDA 510(k) clearance on 2002-01-17. The listed applicant is Meretek Diagnostics, Inc.. The 510(k) number is K014225.

When did BREATHTEK - UBIT UBT FOR H. PYLORI receive FDA 510(k) clearance?

BREATHTEK - UBIT UBT FOR H. PYLORI received FDA 510(k) clearance on 2002-01-17, under 510(k) number K014225.

Who is the listed applicant for BREATHTEK - UBIT UBT FOR H. PYLORI?

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

What is the FDA product code for BREATHTEK - UBIT UBT FOR H. PYLORI?

The FDA product code for BREATHTEK - UBIT UBT FOR H. PYLORI is MSQ.

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Other records listing Meretek Diagnostics, Inc. as applicant

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.

K972352THE MERETEK UBT BREATH TEST FOR H.PYLORIK952220MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT

Related Devices (Code: MSQ)

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.

K221896BreathID Hp SystemMeridian Bioscience Israel , Ltd.K223185BreathID® Smart SystemMeridian Bioscience Israel , Ltd.K220494BreathID Hp Lab System, BreathID Smart SystemMeridian Bioscience Israel , Ltd.K193610BreathID Smart SystemExalenz Bioscience , Ltd.K173772BreathID Hp SystemExalenz Bioscience , Ltd.K173777BreathID Hp Lab SystemExalenz Bioscience , Ltd.

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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