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510(k) K142038

EUROIMMUN LYME ELISA(IgG/IgM) by Euroimmun US — Product Code LSR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2015
Date Received
July 28, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Borrelia Serological Reagent
Device Class
Class II
Regulation Number
866.3830
Review Panel
MI
Submission Type

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  • K141827 — EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE (April 17, 2015)

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