Device Classification Name |
Multi-Analyte Controls, All Kinds (Assayed)
|
510(k) Number |
K942458 |
Device Name |
PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED |
Applicant |
RANDOX LABORATORIES, LTD. |
ARDMORE, DIAMOND ROAD |
CRUMLIN,
IE
BT29 4QY
|
|
Applicant Contact |
John Lamont |
Correspondent |
RANDOX LABORATORIES, LTD. |
ARDMORE, DIAMOND ROAD |
CRUMLIN,
IE
BT29 4QY
|
|
Correspondent Contact |
John Lamont |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 05/24/1994 |
Decision Date | 03/13/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|