Device Classification Name |
Immunoassay Method, Troponin Subunit
|
510(k) Number |
K081643 |
Device Name |
DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692 |
Applicant |
SIEMENS HEALTHCARE DIAGNOSTICS |
MS 514, PO BOX 6101 |
NEWARK,
DE
19714 -6101
|
|
Applicant Contact |
YUK-TING LEWIS |
Correspondent |
SIEMENS HEALTHCARE DIAGNOSTICS |
MS 514, PO BOX 6101 |
NEWARK,
DE
19714 -6101
|
|
Correspondent Contact |
YUK-TING LEWIS |
Regulation Number | 862.1215
|
Classification Product Code |
|
Date Received | 06/12/2008 |
Decision Date | 07/03/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|