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510(k) K022017

RHIGENE MESACUP-2 TEST RNP, MODEL M7741 by Rhigene, Inc. — Product Code LKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2002
Date Received
June 20, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Rnp Antibody, Antigen And Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

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