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510(k) K955431

RIT LIVER, KIDNEY, STOMACH IFA KIT by The Binding Site, Ltd. — Product Code DBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1996
Date Received
November 28, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

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