Device Classification Name |
Enzyme Immunoassay, Barbiturate
|
510(k) Number |
K041712 |
Device Name |
'RAPIDTEC 4' TEST |
Applicant |
AMERICAN BIO MEDICA CORP. |
9110 RED BRANCH ROAD |
SUITE B |
COLUMBIA,
MD
21045
|
|
Applicant Contact |
HENRY WELLS |
Correspondent |
AMERICAN BIO MEDICA CORP. |
9110 RED BRANCH ROAD |
SUITE B |
COLUMBIA,
MD
21045
|
|
Correspondent Contact |
HENRY WELLS |
Regulation Number | 862.3150
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/23/2004 |
Decision Date | 11/03/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|