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FDA 510(k)

QUANTA LITE LKM-1 ELISA

K-Number: K000535 · 2000-06-07

ApplicantInova Diagnostics, Inc.
Decision Date2000-06-07
Product CodeNBS
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTA LITE LKM-1 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 2000-06-07 under 510(k) number K000535. The device is classified under product code NBS. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTA LITE LKM-1 ELISA?

QUANTA LITE LKM-1 ELISA is a medical device that received FDA 510(k) clearance on 2000-06-07. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K000535.

When did QUANTA LITE LKM-1 ELISA receive FDA 510(k) clearance?

QUANTA LITE LKM-1 ELISA received FDA 510(k) clearance on 2000-06-07, under 510(k) number K000535.

Who is the listed applicant for QUANTA LITE LKM-1 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 LKM-1 ELISA?

The FDA product code for QUANTA LITE LKM-1 ELISA is NBS.

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Related Devices (Code: NBS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K163538QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 ControlsInova Diagnostics, Inc.K112223EUROIMMUN ANTI-LKM-1 ELISA(LGG)Euroimmun US

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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