Device Classification Name |
assay, glycosylated hemoglobin
|
510(k) Number |
K120497 |
Device Name |
EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL |
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 | 864.7470
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/21/2012 |
Decision Date | 05/14/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|