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FDA 510(k) Application Details - K183088
Device Classification Name
Assay, Erythropoietin
More FDA Info for this Device
510(K) Number
K183088
Device Name
Assay, Erythropoietin
Applicant
Axis-Shield Diagnostics Limited
Luna Place, The Technology Park
Dundee DD2 1XA GB
Other 510(k) Applications for this Company
Contact
Claire Dora
Other 510(k) Applications for this Contact
Regulation Number
864.7250
More FDA Info for this Regulation Number
Classification Product Code
GGT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/06/2018
Decision Date
08/02/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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