Device Classification Name |
enzyme immunoassay, opiates
|
510(k) Number |
K060351 |
Device Name |
MEDTOX OXYCODONE |
Applicant |
MEDTOX DIAGNOSTICS, INC. |
1238 ANTHONY RD. |
BURLINGTON,
NC
27215
|
|
Applicant Contact |
PHILLIP HARTZOG |
Correspondent |
MEDTOX DIAGNOSTICS, INC. |
1238 ANTHONY RD. |
BURLINGTON,
NC
27215
|
|
Correspondent Contact |
PHILLIP HARTZOG |
Regulation Number | 862.3650
|
Classification Product Code |
|
Date Received | 02/13/2006 |
Decision Date | 05/12/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|