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510(k) K182098

N Latex FLC kappa assay, N Latex FLC lambda assay by Siemens Healthcare Diagnostics Products GmbH — Product Code DFH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2018
Date Received
August 3, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kappa, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
Review Panel
IM
Submission Type

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