Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K050436
Device Classification Name
Counter, Differential Cell
More FDA Info for this Device
510(K) Number
K050436
Device Name
Counter, Differential Cell
Applicant
MELET SCHLOESING LABORATORIES USA
7703 CONVOY CT
SAN DIEGO, CA 92111 US
Other 510(k) Applications for this Company
Contact
JACKIE COLEMAN
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
02/22/2005
Decision Date
07/27/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact