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510(k) K810984

ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST by Immuno-Products Industries — Product Code DBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1981
Date Received
April 13, 1981
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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