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FDA 510(k)

MERETEK UBT_LITE BREATH TEST FOR H. PYLORI

K-Number: K000316 · 2000-02-24

ApplicantMeretek
Decision Date2000-02-24
Product CodeMSQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MERETEK UBT_LITE BREATH TEST FOR H. PYLORI is the device name listed in this FDA 510(k) record. The listed applicant is Meretek. It received FDA 510(k) clearance on 2000-02-24 under 510(k) number K000316. 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 MERETEK UBT_LITE BREATH TEST FOR H. PYLORI?

MERETEK UBT_LITE BREATH TEST FOR H. PYLORI is a medical device that received FDA 510(k) clearance on 2000-02-24. The listed applicant is Meretek. The 510(k) number is K000316.

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

MERETEK UBT_LITE BREATH TEST FOR H. PYLORI received FDA 510(k) clearance on 2000-02-24, under 510(k) number K000316.

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

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

What is the FDA product code for MERETEK UBT_LITE BREATH TEST FOR H. PYLORI?

The FDA product code for MERETEK UBT_LITE BREATH TEST FOR H. PYLORI is MSQ.

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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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