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FDA 510(k) Application Details - K981496
Device Classification Name
System, Test, Rheumatoid Factor
More FDA Info for this Device
510(K) Number
K981496
Device Name
System, Test, Rheumatoid Factor
Applicant
SERADYN, INC.
1200 MADISON AVE.
INDIANAPOLIS, IN 46225 US
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Contact
MARTIN J WEINSTEIN
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
04/27/1998
Decision Date
06/15/1998
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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