Device Classification Name |
radioimmunoassay, morphine (125-i), goat antibody ammonium sulfate sep.
|
510(k) Number |
K002418 |
Device Name |
BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D |
Applicant |
BRANAN MEDICAL CORPORATION |
10015 MUIRLANDS RD. SUITE E |
IRVINE,
CA
92618
|
|
Applicant Contact |
RAPHAEL WONG |
Correspondent |
BRANAN MEDICAL CORPORATION |
10015 MUIRLANDS RD. SUITE E |
IRVINE,
CA
92618
|
|
Correspondent Contact |
RAPHAEL WONG |
Regulation Number | 862.3640
|
Classification Product Code |
|
Date Received | 08/08/2000 |
Decision Date | 11/22/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|