Device Classification Name |
radioimmunoassay, digitoxin (125-i), rabbit antibody, solid phase sep.
|
510(k) Number |
K760077 |
Device Name |
TEST, RIA, SERUM DIGOXIN |
Applicant |
SMITH KLINE DIAGNOSTICS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
SMITH KLINE DIAGNOSTICS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.3300
|
Classification Product Code |
|
Date Received | 06/18/1976 |
Decision Date | 07/16/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|