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FDA 510(k) Application Details - K024067
Device Classification Name
System, Test, Rheumatoid Factor
More FDA Info for this Device
510(K) Number
K024067
Device Name
System, Test, Rheumatoid Factor
Applicant
ABBOTT LABORATORIES
1920 HURD DR.
IRVING, TX 75038 US
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Contact
LINDA MORRIS
Other 510(k) Applications for this Contact
Regulation Number
866.5775
More FDA Info for this Regulation Number
Classification Product Code
DHR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/10/2002
Decision Date
01/15/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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