Device Classification Name |
enzyme immunoassay, amphetamine
|
510(k) Number |
K121065 |
Device Name |
POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE |
Applicant |
POLYMED THERAPEUTICS, INC |
12828 DOE LANE |
GAITHERSBURG,
MD
20878
|
|
Applicant Contact |
JJ XIA |
Correspondent |
POLYMED THERAPEUTICS, INC |
12828 DOE LANE |
GAITHERSBURG,
MD
20878
|
|
Correspondent Contact |
JJ XIA |
Regulation Number | 862.3100
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/06/2012 |
Decision Date | 05/24/2013 |
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
|
|
|