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510(k) K974429

RAPET CRP by Stanbio Laboratory — Product Code DCN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1998
Date Received
November 24, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, C-Reactive Protein
Device Class
Class II
Regulation Number
866.5270
Review Panel
IM
Submission Type

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