Device Classification Name |
assay, glycosylated hemoglobin
|
510(k) Number |
K023763 |
Device Name |
RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS |
Applicant |
RANDOX LABORATORIES, LTD. |
ARDMORE, DIAMOND ROAD |
CRUMLIN, CO. ANTRIM,
GB
BT29 4QY
|
|
Applicant Contact |
LYNNE HAMILTON |
Correspondent |
RANDOX LABORATORIES, LTD. |
ARDMORE, DIAMOND ROAD |
CRUMLIN, CO. ANTRIM,
GB
BT29 4QY
|
|
Correspondent Contact |
LYNNE HAMILTON |
Regulation Number | 864.7470
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/08/2002 |
Decision Date | 01/13/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|