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510(k) K192116

Human IgA liquid reagent kit for Use on SPAPlus by The Binding Site Group , Ltd. — Product Code CFN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2019
Date Received
August 6, 2019
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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