Device Classification Name |
Method, Nephelometric, Immunoglobulins (G, A, M)
|
510(k) Number |
K032014 |
Device Name |
N LATEX IGM |
Applicant |
DADE BEHRING, INC. |
GLASGOW SITE |
P.O. BOX 6101 |
NEWARK,
DE
19714 -6101
|
|
Applicant Contact |
KATHLEEN A DRAY-LYONS |
Correspondent |
DADE BEHRING, INC. |
GLASGOW SITE |
P.O. BOX 6101 |
NEWARK,
DE
19714 -6101
|
|
Correspondent Contact |
KATHLEEN A DRAY-LYONS |
Regulation Number | 866.5510
|
Classification Product Code |
|
Date Received | 06/30/2003 |
Decision Date | 08/07/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|