Device Classification Name |
Radioimmunoassay, Digitoxin (125-I)
|
510(k) Number |
K780766 |
Device Name |
(125 I) DIGITOXIN RIA KIT |
Applicant |
DIAGNOSTIC PRODUCTS CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
DIAGNOSTIC PRODUCTS CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.3300
|
Classification Product Code |
|
Date Received | 05/05/1978 |
Decision Date | 07/27/1978 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|