Device Classification Name |
Control, Plasma, Abnormal
|
510(k) Number |
K945856 |
Device Name |
POSITIVE LUPUS ANTICOAGULANT PLASMA |
Applicant |
George King Bio-Medical, Inc. |
11771 WEST 112TH ST. |
OVERLAND PARK,
KS
66210
|
|
Applicant Contact |
JUDITH A GILLISSEN |
Correspondent |
George King Bio-Medical, Inc. |
11771 WEST 112TH ST. |
OVERLAND PARK,
KS
66210
|
|
Correspondent Contact |
JUDITH A GILLISSEN |
Regulation Number | 864.5425
|
Classification Product Code |
|
Date Received | 11/14/1994 |
Decision Date | 10/05/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|