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FDA 510(k)

QUANTA LITE SP100 ELISA

K-Number: K050662 · 2005-06-13

ApplicantInova Diagnostics, Inc.
Decision Date2005-06-13
Product CodeNUM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTA LITE SP100 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 2005-06-13 under 510(k) number K050662. The device is classified under product code NUM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTA LITE SP100 ELISA?

QUANTA LITE SP100 ELISA is a medical device that received FDA 510(k) clearance on 2005-06-13. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K050662.

When did QUANTA LITE SP100 ELISA receive FDA 510(k) clearance?

QUANTA LITE SP100 ELISA received FDA 510(k) clearance on 2005-06-13, under 510(k) number K050662.

Who is the listed applicant for QUANTA LITE SP100 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 SP100 ELISA?

The FDA product code for QUANTA LITE SP100 ELISA is NUM.

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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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