Device Classification Name |
Antisera, Cf, Influenza Virus A, B, C
More FDA Info for this Device |
510(K) Number |
K081746 |
Device Name |
Antisera, Cf, Influenza Virus A, B, C |
Applicant |
DIAGNOSTIC HYBRIDS, INC.
1055 EAST STATE STREET
SUITE 100
ATHENS, OH 45701 US
Other 510(k) Applications for this Company
|
Contact |
GAIL R GOODRUM
Other 510(k) Applications for this Contact |
Regulation Number |
866.3330
More FDA Info for this Regulation Number |
Classification Product Code |
GNW
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
06/19/2008 |
Decision Date |
12/23/2008 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
MI - Microbiology |
Review Advisory Committee |
MI - Microbiology |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|