Device Classification Name |
reagent, russel viper venom
|
510(k) Number |
K132130 |
Device Name |
REAGENT, RUSSEL VIPER VENOM - LA SCREEN |
Applicant |
DSRV, INC. |
780 PARK NORTH BLVD. |
SUITE 100 |
Clarkston,
GA
30021
|
|
Applicant Contact |
LAWANDA WASHINGTON |
Correspondent |
DSRV, INC. |
780 PARK NORTH BLVD. |
SUITE 100 |
Clarkston,
GA
30021
|
|
Correspondent Contact |
LAWANDA WASHINGTON |
Regulation Number | 864.8950
|
Classification Product Code |
|
Date Received | 07/10/2013 |
Decision Date | 01/10/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|