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FDA 510(k) Application Details - K170413
Device Classification Name
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
More FDA Info for this Device
510(K) Number
K170413
Device Name
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Applicant
Bio-Rad Laboratories
5500 E. 2nd Street
Benicia, CA 94510 US
Other 510(k) Applications for this Company
Contact
Juang Wang
Other 510(k) Applications for this Contact
Regulation Number
866.3830
More FDA Info for this Regulation Number
Classification Product Code
LIP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/10/2017
Decision Date
05/11/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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