Device Classification Name |
Enzyme Immunoassay, Digoxin
|
510(k) Number |
K851032 |
Device Name |
COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C |
Applicant |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
11 FRANKLIN AVE. |
BELLEVILLE,
NJ
07109 -3597
|
|
Applicant Contact |
KAFADER II |
Correspondent |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
11 FRANKLIN AVE. |
BELLEVILLE,
NJ
07109 -3597
|
|
Correspondent Contact |
KAFADER II |
Regulation Number | 862.3320
|
Classification Product Code |
|
Date Received | 03/12/1985 |
Decision Date | 04/03/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|