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FDA 510(k) Application Details - K192727
Device Classification Name
System, Test, Rheumatoid Factor
More FDA Info for this Device
510(K) Number
K192727
Device Name
System, Test, Rheumatoid Factor
Applicant
Kamiya Biomedical Company
12779 Gateway Drive S
Tukwila, WA 98168 US
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Contact
Shawn Kaplan
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
09/27/2019
Decision Date
05/20/2020
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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