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

FDA 510(k) K163538 · Inova Diagnostics, Inc.

Substantially Equivalent

510(k) numberK163538

Submission

Device name
QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls
Applicant
Inova Diagnostics, Inc.
San Diego, CA, US
Received
December 16, 2016
Decision date
September 6, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NBS – Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5660
Specialty
Immunology

Other 510(k)s with product code NBS

510(k)DeviceApplicantDecision
K112223Euroimmun ANTI-LKM-1 Elisa(Lgg)NBS · Traditional Euroimmun US09/11/2012SE
K000535Quanta Lite LKM-1 ElisaNBS · Traditional Inova Diagnostics, Inc.06/07/2000SE

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Questions and answers

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

QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls (K163538) received a 510(k) decision of Substantially Equivalent on September 6, 2017, 264 days after the submission was received.

What is the product code of K163538?

The FDA product code is NBS – Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1), a Class II (moderate risk) device regulated under 21 CFR 866.5660.