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FDA 510(k) Application Details - K192028
Device Classification Name
C-Reactive Protein, Antigen, Antiserum, And Control
More FDA Info for this Device
510(K) Number
K192028
Device Name
C-Reactive Protein, Antigen, Antiserum, And Control
Applicant
Horiba ABX SAS
Parc Euromedecine, Rue du Caducee BP7290
Montpellier Cedex 4 341184 FR
Other 510(k) Applications for this Company
Contact
Caroline Ferrer
Other 510(k) Applications for this Contact
Regulation Number
866.5270
More FDA Info for this Regulation Number
Classification Product Code
DCK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/26/2019
Decision Date
06/25/2020
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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