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510(k) K031308

RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 by Rhigene, Inc. — Product Code DBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2003
Date Received
April 24, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5090
Review Panel
IM
Submission Type

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