Device Classification Name |
calibrator, secondary
|
510(k) Number |
K103836 |
Device Name |
ENZYME II CALIBRATOR |
Applicant |
SIEMENS HEALTHCARE DIAGNOSTICS INC |
500 GBC DRIVE |
P.O. BOX 6101 |
NEWARK,
DE
19714 -6101
|
|
Applicant Contact |
ANNA MARIE KATH ENNIS |
Correspondent |
SIEMENS HEALTHCARE DIAGNOSTICS INC |
500 GBC DRIVE |
P.O. BOX 6101 |
NEWARK,
DE
19714 -6101
|
|
Correspondent Contact |
ANNA MARIE KATH ENNIS |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 12/30/2010 |
Decision Date | 02/16/2011 |
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
|
|
|