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510(k) K022946

LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST by Princeton BioMeditech Corp. — Product Code MMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2002
Date Received
September 4, 2002
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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