Device Classification Name |
enzyme immunoassay, benzodiazepine
|
510(k) Number |
K790736 |
Device Name |
EMIT-TOX SERUM BENZODIAZEPINE 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 | 862.3170
|
Classification Product Code |
|
Date Received | 04/16/1979 |
Decision Date | 04/26/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|