Device Classification Name |
Calibrator, Multi-Analyte Mixture
|
510(k) Number |
K031608 |
Device Name |
RANDOX LIQUID PROTEIN CALIBRATOR |
Applicant |
RANDOX LABORATORIES, LTD. |
ARDMORE, DIAMOND ROAD |
CRUMLIN, CO. ANTRIM,
GB
BT29 4QY
|
|
Applicant Contact |
P. ARMSTRONG |
Correspondent |
RANDOX LABORATORIES, LTD. |
ARDMORE, DIAMOND ROAD |
CRUMLIN, CO. ANTRIM,
GB
BT29 4QY
|
|
Correspondent Contact |
P. ARMSTRONG |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 05/22/2003 |
Decision Date | 08/08/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|