SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE


Device Classification Name

counter, urine particle

510(k) Number K080887
Device Name SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE
Applicant
SYSMEX AMERICA, INC.
one nelson c. white parkway
mundelein, 
IL 
60060

Applicant Contact nina gamperling
Correspondent
SYSMEX AMERICA, INC.
one nelson c. white parkway
mundelein, 
IL 
60060

Correspodent Contact nina gamperling
Regulation Number 864.5200
Classification Product Code
LKM  
Date Received 03/31/2008
Decision Date 05/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Pathology

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls