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FDA 510(k)

MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT

K-Number: K952220 · 1996-09-17

ApplicantMeretek Diagnostics, Inc.
Decision Date1996-09-17
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT 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 1996-09-17 under 510(k) number K952220. 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 MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT?

MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT is a medical device that received FDA 510(k) clearance on 1996-09-17. The listed applicant is Meretek Diagnostics, Inc.. The 510(k) number is K952220.

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

MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT received FDA 510(k) clearance on 1996-09-17, under 510(k) number K952220.

Who is the listed applicant for MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT?

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 MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT?

The FDA product code for MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT is LYR.

Related Clinical Trials

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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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. PYLORIK972352THE MERETEK UBT BREATH TEST FOR H.PYLORI

Related Devices (Code: LYR)

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.

K232892Hp Detect™ Stool Antigen ELISABiomerica, Inc.K230901Premier HpSA Flex (619096)Meridian Bioscience, Inc.K192817Curian HpSA, Curian AnalyzerMeridian Bioscience, Inc.K183573Vstrip H. pylori Antigen Rapid TestPanion & BF Biotech, Inc.K182559PREMIER Platinum HpSA PLUSMeridian Bioscience, Inc.K181464LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetDiaSorin, Inc.

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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