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510(k) K122553

MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM by ACON Laboratories, Inc. — Product Code GKR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2013
Date Received
August 21, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Hemoglobin, Automated
Device Class
Class II
Regulation Number
864.5620
Review Panel
HE
Submission Type

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