Device Classification Name |
Enzyme Immunoassay, Phenobarbital
|
510(k) Number |
K000012 |
Device Name |
IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5 |
Applicant |
DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. |
LOS ANGELES,
CA
90045 -5597
|
|
Applicant Contact |
EDWARD M LEVINE |
Correspondent |
DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. |
LOS ANGELES,
CA
90045 -5597
|
|
Correspondent Contact |
EDWARD M LEVINE |
Regulation Number | 862.3660
|
Classification Product Code |
|
Date Received | 01/03/2000 |
Decision Date | 03/03/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|