Device Classification Name |
reagent, russel viper venom
|
510(k) Number |
K000527 |
Device Name |
ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 |
Applicant |
SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. |
ST. LOUIS,
MO
63103
|
|
Applicant Contact |
WILLIAM R GILBERT |
Correspondent |
SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. |
ST. LOUIS,
MO
63103
|
|
Correspondent Contact |
WILLIAM R GILBERT |
Regulation Number | 864.8950
|
Classification Product Code |
|
Date Received | 02/17/2000 |
Decision Date | 04/07/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|