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FDA 510(k)

QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA

K-Number: K010558 · 2001-04-03

ApplicantInova Diagnostics, Inc.
Decision Date2001-04-03
Product CodeMLE
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) 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 2001-04-03 under 510(k) number K010558. The device is classified under product code MLE. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA?

QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA is a medical device that received FDA 510(k) clearance on 2001-04-03. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K010558.

When did QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA receive FDA 510(k) clearance?

QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA received FDA 510(k) clearance on 2001-04-03, under 510(k) number K010558.

Who is the listed applicant for QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) 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 GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA?

The FDA product code for QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA is MLE.

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Related Devices (Code: MLE)

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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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