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FDA 510(k) Application Details - K993843
Device Classification Name
System, Test, Rheumatoid Factor
More FDA Info for this Device
510(K) Number
K993843
Device Name
System, Test, Rheumatoid Factor
Applicant
MICRO DETECT, INC.
2852 WALNUT AVE., SUITE H-1
TUSTIN, CA 92780 US
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Contact
MEHDI ALEM
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Regulation Number
866.5775
More FDA Info for this Regulation Number
Classification Product Code
DHR
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More FDA Info for this Product Code
Date Received
11/12/1999
Decision Date
01/11/2000
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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