Device Classification Name |
Immunoassay Method, Troponin Subunit
|
510(k) Number |
K010313 |
Device Name |
DIMENSION CTNI FLEX REAGENT CARTRIDGE |
Applicant |
DADE BEHRING, INC. |
P.O. BOX 6101, BUILDING 500 |
NEWARK,
DE
19714
|
|
Applicant Contact |
GEORGE PLUMMER |
Correspondent |
DADE BEHRING, INC. |
P.O. BOX 6101, BUILDING 500 |
NEWARK,
DE
19714
|
|
Correspondent Contact |
GEORGE PLUMMER |
Regulation Number | 862.1215
|
Classification Product Code |
|
Date Received | 02/02/2001 |
Decision Date | 04/20/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|