Device Classification Name |
Method, Nephelometric, Immunoglobulins (G, A, M)
More FDA Info for this Device |
510(K) Number |
K993549 |
Device Name |
Method, Nephelometric, Immunoglobulins (G, A, M) |
Applicant |
BECKMAN COULTER, INC.
200 S. KRAEMER BLVD.,M/S W-104
BOX 8000
BREA, CA 92822-8000 US
Other 510(k) Applications for this Company
|
Contact |
RICHARD T ROSS
Other 510(k) Applications for this Contact |
Regulation Number |
866.5510
More FDA Info for this Regulation Number |
Classification Product Code |
CFN
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
10/19/1999 |
Decision Date |
02/01/2000 |
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 |
|