Device Classification Name |
enzyme immunoassay, methadone
|
510(k) Number |
K000466 |
Device Name |
URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A |
Applicant |
DADE BEHRING, INC. |
RT. 896, GLASCOW BLDG. 500 |
NEWARK,
DE
19714
|
|
Applicant Contact |
JUDY MCINNIS-BERGER |
Correspondent |
DADE BEHRING, INC. |
RT. 896, GLASCOW BLDG. 500 |
NEWARK,
DE
19714
|
|
Correspondent Contact |
JUDY MCINNIS-BERGER |
Regulation Number | 862.3620
|
Classification Product Code |
|
Date Received | 02/11/2000 |
Decision Date | 04/05/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|