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FDA 510(k)

QUANTA LITE GP210 ELISA

K-Number: K040885 · 2004-06-25

ApplicantInova Diagnostics, Inc.
Decision Date2004-06-25
Product CodeNRI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTA LITE GP210 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 2004-06-25 under 510(k) number K040885. The device is classified under product code NRI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTA LITE GP210 ELISA?

QUANTA LITE GP210 ELISA is a medical device that received FDA 510(k) clearance on 2004-06-25. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K040885.

When did QUANTA LITE GP210 ELISA receive FDA 510(k) clearance?

QUANTA LITE GP210 ELISA received FDA 510(k) clearance on 2004-06-25, under 510(k) number K040885.

Who is the listed applicant for QUANTA LITE GP210 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 GP210 ELISA?

The FDA product code for QUANTA LITE GP210 ELISA is NRI.

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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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