Device Classification Name |
calibrators, ethyl alcohol
|
510(k) Number |
K802620 |
Device Name |
EMIT-STM ETHYL ALCOHOL URINE CALIBRATOR |
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 | 862.3200
|
Classification Product Code |
|
Date Received | 10/20/1980 |
Decision Date | 10/31/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|