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510(k) K000535

QUANTA LITE LKM-1 ELISA by Inova Diagnostics, Inc. — Product Code NBS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2000
Date Received
February 17, 2000
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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