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510(k) K233663

N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) by Siemens Healthcare Diagnostics Products GmbH — Product Code CFN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2023
Date Received
November 15, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Method, Nephelometric, Immunoglobulins (G, A, M)
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

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