Device Classification Name |
Calibrator, Primary
|
510(k) Number |
K013126 |
Device Name |
N LP(A) STANDARD SY |
Applicant |
DADE BEHRING, INC. |
GLASGOW SITE |
P.O. BOX 6101 |
NEWARK,
DE
19714 -6101
|
|
Applicant Contact |
REBECCA S AYASH |
Correspondent |
DADE BEHRING, INC. |
GLASGOW SITE |
P.O. BOX 6101 |
NEWARK,
DE
19714 -6101
|
|
Correspondent Contact |
REBECCA S AYASH |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 09/19/2001 |
Decision Date | 11/09/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|