Device Classification Name |
Transferrin, Rhodamine, Antigen, Antiserum, Control
More FDA Info for this Device |
510(K) Number |
K963139 |
Device Name |
Transferrin, Rhodamine, Antigen, Antiserum, Control |
Applicant |
OLYMPUS AMERICA, INC.
TWO CORPORATE CENTER DR.
MELVILLE, NY 11747-3157 US
Other 510(k) Applications for this Company
|
Contact |
LAURA STORMS-TYLER
Other 510(k) Applications for this Contact |
Regulation Number |
866.5880
More FDA Info for this Regulation Number |
Classification Product Code |
DDD
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
08/12/1996 |
Decision Date |
02/06/1997 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
IM - Immunology |
Review Advisory Committee |
IM - Immunology |
Statement / Summary / Purged Status |
Statement |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|