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FDA 510(k)

QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls

K-Number: K163538 · 2017-09-06

ApplicantInova Diagnostics, Inc.
Decision Date2017-09-06
Product CodeNBS
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls is a medical device manufactured by Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2017-09-06 under approval number K163538. 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 Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls?

QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls is a medical device that received FDA 510(k) clearance on 2017-09-06. It is manufactured by Inova Diagnostics, Inc.. The 510(k) number is K163538.

When was QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls approved by the FDA?

QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls received FDA 510(k) clearance on 2017-09-06, under approval number K163538.

What company makes QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls?

QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls is manufactured by Inova Diagnostics, Inc..

What is the FDA product code for QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls?

The FDA product code for QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls is NBS.

Other Devices by Inova Diagnostics, Inc.

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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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