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FDA 510(k)

QUANTA LITE H. PYLORI IGG ELISA

K-Number: K982790 · 1998-11-04

ApplicantInova Diagnostics, Inc.
Decision Date1998-11-04
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QUANTA LITE H. PYLORI IGG 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 1998-11-04 under 510(k) number K982790. 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 IGG ELISA?

QUANTA LITE H. PYLORI IGG ELISA is a medical device that received FDA 510(k) clearance on 1998-11-04. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K982790.

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

QUANTA LITE H. PYLORI IGG ELISA received FDA 510(k) clearance on 1998-11-04, under 510(k) number K982790.

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

The FDA product code for QUANTA LITE H. PYLORI IGG 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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