Device Classification Name |
Assay, Glycosylated Hemoglobin
|
510(k) Number |
K121492 |
Device Name |
UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT |
Applicant |
BECKMAN COULTER, INC. |
250 SOUTH KRAEMER BLVD |
A2.SW.09 |
BREA,
CA
92822
|
|
Applicant Contact |
ANNETTE HELLIE |
Correspondent |
BECKMAN COULTER, INC. |
250 SOUTH KRAEMER BLVD |
A2.SW.09 |
BREA,
CA
92822
|
|
Correspondent Contact |
ANNETTE HELLIE |
Regulation Number | 864.7470
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/21/2012 |
Decision Date | 09/11/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|