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510(k) K190879

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2019
Date Received
April 4, 2019
Clearance Type
Special
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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