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510(k) K982121

ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT by Trace Scientific , Ltd. — Product Code DBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1998
Date Received
June 16, 1998
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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