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FDA 510(k) Application Details - K962050
Device Classification Name
System, Test, Rheumatoid Factor
More FDA Info for this Device
510(K) Number
K962050
Device Name
System, Test, Rheumatoid Factor
Applicant
THERATEST LABORATORIES, INC.
2201 WEST CAMPBELL PARK DR.
CHICAGO, IL 60612-3501 US
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Contact
MARIUS TEODORESCU, MD., PH.D.
Other 510(k) Applications for this Contact
Regulation Number
866.5775
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Classification Product Code
DHR
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More FDA Info for this Product Code
Date Received
05/28/1996
Decision Date
12/16/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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