Device Classification Name |
enzymatic esterase--oxidase, cholesterol
|
510(k) Number |
K072249 |
Device Name |
EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT |
Applicant |
MEDICA CORP. |
163 CABOT STREET |
BEVERLY,
MA
01915
|
|
Applicant Contact |
FRAN WHITE |
Correspondent |
MEDICA CORP. |
163 CABOT STREET |
BEVERLY,
MA
01915
|
|
Correspondent Contact |
FRAN WHITE |
Regulation Number | 862.1175
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/13/2007 |
Decision Date | 02/20/2008 |
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
|
|
|