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FDA 510(k)

THE MERETEK UBT BREATH TEST FOR H.PYLORI

K-Number: K972352 · 1997-10-29

ApplicantMeretek Diagnostics, Inc.
Decision Date1997-10-29
Product CodeMSQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

THE MERETEK UBT BREATH TEST 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 1997-10-29 under 510(k) number K972352. 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 THE MERETEK UBT BREATH TEST FOR H.PYLORI?

THE MERETEK UBT BREATH TEST FOR H.PYLORI is a medical device that received FDA 510(k) clearance on 1997-10-29. The listed applicant is Meretek Diagnostics, Inc.. The 510(k) number is K972352.

When did THE MERETEK UBT BREATH TEST FOR H.PYLORI receive FDA 510(k) clearance?

THE MERETEK UBT BREATH TEST FOR H.PYLORI received FDA 510(k) clearance on 1997-10-29, under 510(k) number K972352.

Who is the listed applicant for THE MERETEK UBT BREATH TEST 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 THE MERETEK UBT BREATH TEST FOR H.PYLORI?

The FDA product code for THE MERETEK UBT BREATH TEST 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.

K014225BREATHTEK - UBIT UBT 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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