Device Classification Name |
calibrator, multi-analyte mixture
|
510(k) Number |
K080404 |
Device Name |
EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR |
Applicant |
MEDICA CORP. |
5 OAK PARK DRIVE |
BEDFORD,
MA
01730
|
|
Applicant Contact |
Photios Makris |
Correspondent |
MEDICA CORP. |
5 OAK PARK DRIVE |
BEDFORD,
MA
01730
|
|
Correspondent Contact |
Photios Makris |
Regulation Number | 862.1150
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/14/2008 |
Decision Date | 03/13/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|