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FDA 510(k)

EZ-HBT HELICOBACTER BLOOD TEST

K-Number: K990931 · 1999-09-24

ApplicantMetabolic Solutions, Inc.
Decision Date1999-09-24
Product CodeMSQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EZ-HBT HELICOBACTER BLOOD TEST is the device name listed in this FDA 510(k) record. The listed applicant is Metabolic Solutions, Inc.. It received FDA 510(k) clearance on 1999-09-24 under 510(k) number K990931. 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 EZ-HBT HELICOBACTER BLOOD TEST?

EZ-HBT HELICOBACTER BLOOD TEST is a medical device that received FDA 510(k) clearance on 1999-09-24. The listed applicant is Metabolic Solutions, Inc.. The 510(k) number is K990931.

When did EZ-HBT HELICOBACTER BLOOD TEST receive FDA 510(k) clearance?

EZ-HBT HELICOBACTER BLOOD TEST received FDA 510(k) clearance on 1999-09-24, under 510(k) number K990931.

Who is the listed applicant for EZ-HBT HELICOBACTER BLOOD TEST?

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

What is the FDA product code for EZ-HBT HELICOBACTER BLOOD TEST?

The FDA product code for EZ-HBT HELICOBACTER BLOOD TEST 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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