Device Classification Name |
test, qualitative and quantitative factor deficiency
|
510(k) Number |
K050365 |
Device Name |
BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 |
Applicant |
HYPHEN BIOMED |
6560 GOVE CT. |
MASON,
OH
45040
|
|
Applicant Contact |
OLA ANDERSON |
Correspondent |
HYPHEN BIOMED |
6560 GOVE CT. |
MASON,
OH
45040
|
|
Correspondent Contact |
OLA ANDERSON |
Regulation Number | 864.7290
|
Classification Product Code |
|
Date Received | 02/14/2005 |
Decision Date | 12/27/2005 |
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
|
|
|