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510(k) K140224

EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) by Euroimmun US — Product Code LKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2014
Date Received
January 29, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Rnp Antibody, Antigen And Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

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  • K984476 — LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207 (December 22, 1998)
  • K983465 — THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LIN (November 18, 1998)