Device Classification Name |
immunoassay method, troponin subunit
|
510(k) Number |
K190675 |
Device Name |
Dimension EXL High-Sensitivity Troponin I (TNIH) Assay |
Applicant |
Siemens Healthcare Diagnostics, Inc. |
500 GBC Drive |
Newark,
DE
19714
|
|
Applicant Contact |
Laura J. Duggan |
Correspondent |
Siemens Healthcare Diagnostics, Inc. |
500 GBC Drive |
Newark,
DE
19714
|
|
Correspondent Contact |
Laura J. Duggan |
Regulation Number | 862.1215
|
Classification Product Code |
|
Date Received | 03/15/2019 |
Decision Date | 05/17/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|