Device Classification Name |
control, hemoglobin
|
510(k) Number |
K964052 |
Device Name |
HEMOCUE HEMOTROL |
Applicant |
DIRECT SOLUTIONS |
7 HAYRICK LN. |
P.O. BOX 900 |
WESTFORD,
MA
01886
|
|
Applicant Contact |
BILL DONOHUE |
Correspondent |
DIRECT SOLUTIONS |
7 HAYRICK LN. |
P.O. BOX 900 |
WESTFORD,
MA
01886
|
|
Correspondent Contact |
BILL DONOHUE |
Regulation Number | 864.8625
|
Classification Product Code |
|
Date Received | 09/30/1996 |
Decision Date | 11/06/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|