Device Classification Name |
radioimmunoassay, digoxin (125-i), rabbit antibody, charcoal sep.
|
510(k) Number |
K823014 |
Device Name |
DIGOXIN KIT |
Applicant |
PCL-RIA, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
PCL-RIA, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.3320
|
Classification Product Code |
|
Date Received | 10/13/1982 |
Decision Date | 11/01/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|