Device Classification Name |
automated urinalysis system
|
510(k) Number |
K093098 |
Device Name |
AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM |
Applicant |
ARKRAY, INC. |
1201 RICHARDSON DRIVE |
SUITE 140 |
RICHARDSON,
TX
75080
|
|
Applicant Contact |
KENNETH L BLOCK |
Correspondent |
ARKRAY, INC. |
1201 RICHARDSON DRIVE |
SUITE 140 |
RICHARDSON,
TX
75080
|
|
Correspondent Contact |
KENNETH L BLOCK |
Regulation Number | 862.2900
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/01/2009 |
Decision Date | 12/23/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|