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510(k) K042442

QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE by Orion Diagnostica, OY — Product Code DCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2004
Date Received
September 9, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
C-Reactive Protein, Antigen, Antiserum, And Control
Device Class
Class II
Regulation Number
866.5270
Review Panel
IM
Submission Type

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