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510(k) K163538

QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls by Inova Diagnostics, Inc. — Product Code NBS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2017
Date Received
December 16, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

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Other clearances for product code NBS

  • K112223 — EUROIMMUN ANTI-LKM-1 ELISA(LGG) (September 11, 2012)
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