Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K093861
Device Classification Name
Counter, Urine Particle
More FDA Info for this Device
510(K) Number
K093861
Device Name
Counter, Urine Particle
Applicant
IRIS INTERNATIONAL, INC.
9172 ETON AVE.
CHATSWORTH, CA 91311 US
Other 510(k) Applications for this Company
Contact
ELLEN JOHNSTON
Other 510(k) Applications for this Contact
Regulation Number
864.5200
More FDA Info for this Regulation Number
Classification Product Code
LKM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/16/2009
Decision Date
02/05/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
PA - Pathology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact