Device Classification Name |
enzymatic method, creatinine
|
510(k) Number |
K142391 |
Device Name |
Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) |
Applicant |
ACON LABORATORIES, INC. |
10125 MESA RIM ROAD |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
QIYI XIE |
Correspondent |
ACON LABORATORIES, INC. |
10125 MESA RIM ROAD |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
QIYI XIE |
Regulation Number | 862.1225
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/27/2014 |
Decision Date | 12/22/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|