MISSION U500 URINE ANALYZER


Device Classification Name

blood, occult, colorimetric, in urine

510(k) Number K111221
Device Name MISSION U500 URINE ANALYZER
Applicant
ACON LABORATORIES, INC.
10125 mesa rim rd.
san diego, 
CA 
92121

Applicant Contact qiyi xie
Correspondent
ACON LABORATORIES, INC.
10125 mesa rim rd.
san diego, 
CA 
92121

Correspodent Contact qiyi xie
Regulation Number 864.6550
Classification Product Code
JIO  
Subsequent Product Codes
CDM   CEN   JIL   JIN   JIR  
JJB   JMA   JRE   KQO   LJX   NGJ  
Date Received 05/02/2011
Decision Date 01/18/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No