Device Classification Name |
ldl & vldl precipitation, cholesterol via esterase-oxidase, hdl
|
510(k) Number |
K982341 |
Device Name |
DIRECT HDL-CHOLESTROL LIQUID |
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 | 862.1475
|
Classification Product Code |
|
Date Received | 06/22/1998 |
Decision Date | 07/30/1998 |
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
|
|
|