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510(k) K911610

ELISA COMBI-KIT HUMAN IGG SUBCLASSES by Janssen Research Foundation — Product Code DEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1991
Date Received
March 25, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igg, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

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