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510(k) K091991

EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200 by Medica Corp. — Product Code CIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2009
Date Received
July 2, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diazo Colorimetry, Bilirubin
Device Class
Class II
Regulation Number
862.1110
Review Panel
CH
Submission Type

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