Device Classification Name |
gas chromatography, phenobarbital
|
510(k) Number |
K843440 |
Device Name |
MINGO LOG 7 |
Applicant |
SIEMENS ELEMA AB |
BURDITT, BOWLES & RADZIUS |
135 SOUTH LASALLE STREET |
CHICAGO ,
IL
60603 -
|
|
Applicant Contact |
JOSEPH R RADZIUS |
Correspondent |
SIEMENS ELEMA AB |
BURDITT, BOWLES & RADZIUS |
135 SOUTH LASALLE STREET |
CHICAGO ,
IL
60603 -
|
|
Correspondent Contact |
JOSEPH R RADZIUS |
Regulation Number | 862.3660
|
Classification Product Code |
|
Date Received | 09/04/1984 |
Decision Date | 09/04/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|