Device Classification Name |
Calibrator, Multi-Analyte Mixture
|
510(k) Number |
K123372 |
Device Name |
ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR |
Applicant |
ABBOTT LABORATORIES |
1921 HURD DR. |
IRVING,
TX
75038
|
|
Applicant Contact |
LINDA MORRIS |
Correspondent |
ABBOTT LABORATORIES |
1921 HURD DR. |
IRVING,
TX
75038
|
|
Correspondent Contact |
LINDA MORRIS |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 11/01/2012 |
Decision Date | 01/14/2013 |
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
|
|
|