Device Classification Name |
counter, differential cell
|
510(k) Number |
K071562 |
Device Name |
D3 HEMATOLOGY ANALYZER, MODEL D3 |
Applicant |
DREW SCIENTIFIC, INC. |
4230 SHILLING WAY |
DALLAS,
TX
75237
|
|
Applicant Contact |
ROGER BOURREE |
Correspondent |
DREW SCIENTIFIC, INC. |
4230 SHILLING WAY |
DALLAS,
TX
75237
|
|
Correspondent Contact |
ROGER BOURREE |
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 06/07/2007 |
Decision Date | 12/11/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|