Device Classification Name |
Calibrator, Multi-Analyte Mixture
|
510(k) Number |
K897071 |
Device Name |
ROCHE STANDARDS FOR THE COBAS ISE MODULE |
Applicant |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
ONE SUNSET AVE. |
MONTCLAIR,
NJ
07042
|
|
Applicant Contact |
ALEX WESOLOWSKI |
Correspondent |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
ONE SUNSET AVE. |
MONTCLAIR,
NJ
07042
|
|
Correspondent Contact |
ALEX WESOLOWSKI |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 12/22/1989 |
Decision Date | 03/09/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|