Device Classification Name |
multi-analyte controls, all kinds (assayed)
|
510(k) Number |
K121603 |
Device Name |
RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3 |
Applicant |
RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. |
CRUMLIN, COUNTY ANTRIM,
GB
BT29 4QY
|
|
Applicant Contact |
PAULINE ARMSTRONG |
Correspondent |
RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. |
CRUMLIN, COUNTY ANTRIM,
GB
BT29 4QY
|
|
Correspondent Contact |
PAULINE ARMSTRONG |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 04/06/2012 |
Decision Date | 11/20/2012 |
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
|
|
|