Device Classification Name |
enzyme immunoassay, phenobarbital
|
510(k) Number |
K811621 |
Device Name |
EMIT-ST SERUM PHENOBARBITAL ASSAY |
Applicant |
SYVA CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
SYVA CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.3660
|
Classification Product Code |
|
Date Received | 06/08/1981 |
Decision Date | 06/25/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|