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FDA 510(k)

QUANTA LITE ANA ELISA

K-Number: K991657 · 1999-06-17

ApplicantInova Diagnostics, Inc.
Decision Date1999-06-17
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTA LITE ANA 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 1999-06-17 under 510(k) number K991657. 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 ANA ELISA?

QUANTA LITE ANA ELISA is a medical device that received FDA 510(k) clearance on 1999-06-17. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K991657.

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

QUANTA LITE ANA ELISA received FDA 510(k) clearance on 1999-06-17, under 510(k) number K991657.

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

The FDA product code for QUANTA LITE ANA 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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