Device Classification Name |
calibrator, multi-analyte mixture
|
510(k) Number |
K103403 |
Device Name |
MULTICONSTITUENT CALIBRATOR |
Applicant |
ABBOTT LABORATORIES |
1921 HURD DRIVE |
IRVING,
TX
75038 -4396
|
|
Applicant Contact |
LINDA MORRIS |
Correspondent |
ABBOTT LABORATORIES |
1921 HURD DRIVE |
IRVING,
TX
75038 -4396
|
|
Correspondent Contact |
LINDA MORRIS |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 11/19/2010 |
Decision Date | 02/04/2011 |
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
|
|
|