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FDA 510(k) Application Details - K973464
Device Classification Name
System, Test, Rheumatoid Factor
More FDA Info for this Device
510(K) Number
K973464
Device Name
System, Test, Rheumatoid Factor
Applicant
INSTRUMENTATION LABORATORY CO.
113 HARTWELL AVE.
LEXINGTON, MA 02173 US
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Contact
CAROL MARBLE
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
09/12/1997
Decision Date
10/22/1997
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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