Device Classification Name |
Single (Specified) Analyte Controls (Assayed And Unassayed)
|
510(k) Number |
K121084 |
Device Name |
LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L |
Applicant |
Siemens Healthcare Diagnostics Inc. |
PO BOX 6101 |
MAILSTOP 514 |
NEWARK,
DE
19714 -6101
|
|
Applicant Contact |
FRANCES A DILLON |
Correspondent |
Siemens Healthcare Diagnostics Inc. |
PO BOX 6101 |
MAILSTOP 514 |
NEWARK,
DE
19714 -6101
|
|
Correspondent Contact |
FRANCES A DILLON |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 04/10/2012 |
Decision Date | 05/09/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|