Device Classification Name |
system, hemoglobin, automated
|
510(k) Number |
K032203 |
FOIA Releasable 510(k) |
K032203
|
Device Name |
HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704 |
Applicant |
HEMOCUE, INC. |
9229 CRANFORD DR. |
POTOMAC,
MD
20854
|
|
Applicant Contact |
R. J SLOMOFF |
Correspondent |
HEMOCUE, INC. |
9229 CRANFORD DR. |
POTOMAC,
MD
20854
|
|
Correspondent Contact |
R. J SLOMOFF |
Regulation Number | 864.5620
|
Classification Product Code |
|
Date Received | 07/18/2003 |
Decision Date | 08/25/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|