Device Classification Name |
analyzer, chemistry (photometric, discrete), for clinical use
|
510(k) Number |
K944093 |
Device Name |
DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM |
Applicant |
E.I. DUPONT DE NEMOURS & CO., INC. |
MEDICAL PRODUCTS DEPARTMENT |
BARLEY MILL PLAZA, P22-1170 |
WILMINGTON,
DE
19898
|
|
Applicant Contact |
CAROLYN K GEORGE |
Correspondent |
E.I. DUPONT DE NEMOURS & CO., INC. |
MEDICAL PRODUCTS DEPARTMENT |
BARLEY MILL PLAZA, P22-1170 |
WILMINGTON,
DE
19898
|
|
Correspondent Contact |
CAROLYN K GEORGE |
Regulation Number | 862.2160
|
Classification Product Code |
|
Date Received | 08/22/1994 |
Decision Date | 11/10/1994 |
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
|
|
|