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510(k) K984359

AIA-PACK TROPONIN I ASSAY by Tosoh Medics, Inc. — Product Code MMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1998
Date Received
December 7, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunoassay Method, Troponin Subunit
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

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