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510(k) K894364

MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) by Kronus — Product Code JZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1989
Date Received
July 14, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Thyroid Autoantibody
Device Class
Class II
Regulation Number
866.5870
Review Panel
IM
Submission Type

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