Device Classification Name |
system, hemoglobin, automated
|
510(k) Number |
K961312 |
Device Name |
HEMOCUE B-HEMOGLOBIN SYSTEM |
Applicant |
HEMOCUE, INC. |
C/O ROBERT JOEL SLOMOF |
9229 CRANFORD DRIVE |
POTOMAC,
MD
20854
|
|
Applicant Contact |
ROBERT J SLOMOF |
Correspondent |
HEMOCUE, INC. |
C/O ROBERT JOEL SLOMOF |
9229 CRANFORD DRIVE |
POTOMAC,
MD
20854
|
|
Correspondent Contact |
ROBERT J SLOMOF |
Regulation Number | 864.5620
|
Classification Product Code |
|
Date Received | 04/04/1996 |
Decision Date | 09/24/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|