Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K162462
Device Classification Name
Separator, Automated, Blood Cell, Diagnostic
More FDA Info for this Device
510(K) Number
K162462
Device Name
Separator, Automated, Blood Cell, Diagnostic
Applicant
FRESENIUS KABI USA LLC
THREE CORPORATE DRIVE
LAKE ZURICH, IL 60047 US
Other 510(k) Applications for this Company
Contact
KIM FORCH
Other 510(k) Applications for this Contact
Regulation Number
864.9245
More FDA Info for this Regulation Number
Classification Product Code
GKT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/02/2016
Decision Date
11/23/2016
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact