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510(k) K052262

QUANTA LITE M2 EP (MIT3) ELISA by Inova Diagnostics, Inc. — Product Code DBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2005
Date Received
August 19, 2005
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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