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FDA 510(k)

QUANTA LITE ENA 6 ELISA

K-Number: K961913 · 1996-07-10

ApplicantInova Diagnostics, Inc.
Decision Date1996-07-10
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTA LITE ENA 6 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 1996-07-10 under 510(k) number K961913. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTA LITE ENA 6 ELISA?

QUANTA LITE ENA 6 ELISA is a medical device that received FDA 510(k) clearance on 1996-07-10. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K961913.

When did QUANTA LITE ENA 6 ELISA receive FDA 510(k) clearance?

QUANTA LITE ENA 6 ELISA received FDA 510(k) clearance on 1996-07-10, under 510(k) number K961913.

Who is the listed applicant for QUANTA LITE ENA 6 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 ENA 6 ELISA?

The FDA product code for QUANTA LITE ENA 6 ELISA is LLL.

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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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