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510(k) K193047

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
July 14, 2021
Date Received
November 1, 2019
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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