Device Classification Name |
Method, Nephelometric, Immunoglobulins (G, A, M)
More FDA Info for this Device |
510(K) Number |
K982382 |
Device Name |
Method, Nephelometric, Immunoglobulins (G, A, M) |
Applicant |
ROCHE DIAGNOSTIC SYSTEMS, INC.
BRANCHBURG TOWNSHIP
1080 U.S. HIGHWAY 202
SOMERVILLE, NJ 08876-3771 US
Other 510(k) Applications for this Company
|
Contact |
RITA SMITH
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 |
07/08/1998 |
Decision Date |
09/28/1998 |
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 |
|