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FDA 510(k)

QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT

K-Number: K994004 · 2000-01-27

ApplicantInova Diagnostics, Inc.
Decision Date2000-01-27
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT 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 2000-01-27 under 510(k) number K994004. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT?

QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT is a medical device that received FDA 510(k) clearance on 2000-01-27. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K994004.

When did QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT receive FDA 510(k) clearance?

QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT received FDA 510(k) clearance on 2000-01-27, under 510(k) number K994004.

Who is the listed applicant for QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT?

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 LYME B. BURGDORFERI IGG/IGM ELISA KIT?

The FDA product code for QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT is LSR.

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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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