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FDA 510(k)

QUANTA LITE H.PYLORI IGA ELISA

K-Number: K024334 · 2003-03-27

ApplicantInova Diagnostics, Inc.
Decision Date2003-03-27
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QUANTA LITE H.PYLORI IGA ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2003-03-27 under 510(k) number K024334. 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 QUANTA LITE H.PYLORI IGA ELISA?

QUANTA LITE H.PYLORI IGA ELISA is a medical device that received FDA 510(k) clearance on 2003-03-27. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K024334.

When did QUANTA LITE H.PYLORI IGA ELISA receive FDA 510(k) clearance?

QUANTA LITE H.PYLORI IGA ELISA received FDA 510(k) clearance on 2003-03-27, under 510(k) number K024334.

Who is the listed applicant for QUANTA LITE H.PYLORI IGA ELISA?

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

What is the FDA product code for QUANTA LITE H.PYLORI IGA ELISA?

The FDA product code for QUANTA LITE H.PYLORI IGA ELISA is LYR.

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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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