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510(k) K093834

CRIT-LINE ANEMIA MANAGEMENT SOFTWARE by Hema Metrics, LLC — Product Code MSQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2010
Date Received
December 14, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Urea (Breath Or Blood)
Device Class
Class I
Regulation Number
866.3110
Review Panel
MI
Submission Type

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