Device Classification Name |
Prealbumin, Fitc, Antigen, Antiserum, Control
More FDA Info for this Device |
510(K) Number |
K972812 |
Device Name |
Prealbumin, Fitc, Antigen, Antiserum, Control |
Applicant |
HEMAGEN DIAGNOSTICS, INC.
34-40 BEAR HILL RD.
WALTLHAM, MA 02154 US
Other 510(k) Applications for this Company
|
Contact |
JOSEPH M CALIFANO
Other 510(k) Applications for this Contact |
Regulation Number |
866.5060
More FDA Info for this Regulation Number |
Classification Product Code |
DDS
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
07/28/1997 |
Decision Date |
08/28/1997 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
IM - Immunology |
Review Advisory Committee |
IM - Immunology |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|