Device Classification Name |
automated urinalysis system
|
510(k) Number |
K121456 |
Device Name |
AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL |
Applicant |
ARKRAY, INC. |
5182 West 76th Street |
Edina,
MN
55439
|
|
Applicant Contact |
ADAM ETTL |
Correspondent |
ARKRAY, INC. |
5182 West 76th Street |
Edina,
MN
55439
|
|
Correspondent Contact |
ADAM ETTL |
Regulation Number | 862.2900
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/16/2012 |
Decision Date | 02/01/2013 |
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
|
Recalls |
CDRH Recalls
|