| Device Classification Name |
multi-analyte controls, all kinds (assayed)
|
| 510(K) Number |
K022591 |
| Device Name |
RANDOX LIPID CONTROL |
| Applicant |
| RANDOX LABORATORIES, LTD. |
| ardmore, diamond road |
|
crumlin, co. antrim,
|
|
| Contact |
pauline armstrong |
| Regulation Number | 862.1660
|
| Classification Product Code |
|
| Date Received | 08/05/2002 |
| Decision Date | 08/30/2002 |
| Decision |
substantially equivalent (SE) |
| Classification Advisory Committee |
Clinical Chemistry
|
| Review Advisory Committee |
Clinical Chemistry
|
| statement |
statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Expedited Review |
No
|
| Combination Product |
No
|
|
|