Device Classification Name |
Antisera, Cf, Influenza Virus A, B, C
More FDA Info for this Device |
510(K) Number |
K022713 |
Device Name |
Antisera, Cf, Influenza Virus A, B, C |
Applicant |
DIAGNOSTIC HYBRIDS, INC.
350 WEST STATE ST.
ATHENS, OH 45701 US
Other 510(k) Applications for this Company
|
Contact |
JAMES L BROWN
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 |
08/14/2002 |
Decision Date |
12/18/2002 |
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 |
|