Device Classification Name |
single (specified) analyte controls (assayed and unassayed)
|
510(k) Number |
K042717 |
Device Name |
MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL |
Applicant |
MEDICAL ANALYSIS SYSTEMS, INC. |
5300 ADOLFO RD. |
CAMARILLO,
CA
93012
|
|
Applicant Contact |
MARY THORSNESS |
Correspondent |
MEDICAL ANALYSIS SYSTEMS, INC. |
5300 ADOLFO RD. |
CAMARILLO,
CA
93012
|
|
Correspondent Contact |
MARY THORSNESS |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 09/30/2004 |
Decision Date | 11/05/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|