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510(k) K024067

RHEUMATOID FACTOR (RF) by Abbott Laboratories — Product Code DHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2003
Date Received
December 10, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Rheumatoid Factor
Device Class
Class II
Regulation Number
866.5775
Review Panel
IM
Submission Type

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