Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K193124
Device Classification Name
Counter, Differential Cell
More FDA Info for this Device
510(K) Number
K193124
Device Name
Counter, Differential Cell
Applicant
Beckman Coulter
11800 SW 147th Ave
Miami, FL 33196-2500 US
Other 510(k) Applications for this Company
Contact
Samy Puccio
Other 510(k) Applications for this Contact
Regulation Number
864.5220
More FDA Info for this Regulation Number
Classification Product Code
GKZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/12/2019
Decision Date
04/16/2020
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