Device Classification Name |
device, automated cell-locating
|
510(k) Number |
K984188 |
Device Name |
AUTOMATED CELLULAR IMAGING SYSTEM (ACIS) |
Applicant |
CHROMAVISION MEDICAL SYSTEMS, INC. |
3535 FIREWHEEL DR. |
SUITE A |
FLOWER MOUND,
TX
75028 -2628
|
|
Applicant Contact |
BERTRAM J HUDSON |
Correspondent |
CHROMAVISION MEDICAL SYSTEMS, INC. |
3535 FIREWHEEL DR. |
SUITE A |
FLOWER MOUND,
TX
75028 -2628
|
|
Correspondent Contact |
BERTRAM J HUDSON |
Regulation Number | 864.5260
|
Classification Product Code |
|
Date Received | 11/23/1998 |
Decision Date | 07/28/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|